Contract sterilizerINTERNATIONAL STERILIZATION LABORATORY, LLC (Groveland, FL)FloridaAnesthesiologyEar, nose and throatCardiovascularGastroenterology and urologyGeneral hospitalGeneral and plastic surgeryObstetrics and gynecologyOphthalmicOrthopedicPhysical medicineRadiologyHematologyClass IClass IIClass IIIUnclassified
INTERNATIONAL STERILIZATION LABORATORY, LLC
Contract sterilizer · Groveland, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1061927 (openFDA record; or search FDA's registration database)
- FEI number
- 3000203000
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract sterilizer
- Owner or operator
- INTERNATIONAL STERILIZATION LABORATORY, LLC (FDA owner/operator no. 9051636)
- Registered address
- 217 SAMPEY RD., Groveland, FL 34736
- Contract listings
- 179 device listings, 104 product codes, first listed Dec 29, 2008
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| BSR | Stylet, Tracheal Tube | Class I | Anesthesiology | Contract sterilization | Jan 29, 2013 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | Class II | Ear, nose and throat | Contract sterilization | Jan 28, 2013 |
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | Contract sterilization | Jan 30, 2013 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract sterilization | May 31, 2023 |
| DRC | Trocar | Class II | Cardiovascular | Contract sterilization | Jan 30, 2013 |
| DTB | Permanent Pacemaker Electrode | Class III | Cardiovascular | Contract sterilization | Jan 29, 2013 |
| DTD | Pacemaker Lead Adaptor | Class II | Cardiovascular | Contract sterilization | Jan 30, 2013 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract sterilization | May 30, 2023 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract sterilization | Jan 29, 2013 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract sterilization | Jan 30, 2013 |
| DYG | Catheter, Flow Directed | Class II | Cardiovascular | Contract sterilization | Jan 30, 2013 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract sterilization | Jan 29, 2013 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| FCL | Forceps, Biopsy, Non-Electric | Class I | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| FDX | Endoscopic Cytology Brush | Class II | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| FGX | Snare, Non-Electrical | Class I | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | Class II | Gastroenterology and urology | Contract sterilization | Apr 8, 2013 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Jul 28, 2023 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Jul 11, 2023 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract sterilization | Apr 8, 2013 |
| FSQ | Light, Surgical, Instrument | Class II | General and plastic surgery | Contract sterilization | Jan 29, 2013 |
| FTF | Illuminator, Non-Remote | Class II | General and plastic surgery | Contract sterilization | Jan 29, 2013 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract sterilization | Jan 22, 2016 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract sterilization | Jul 19, 2023 |
| GAP | Suture, Nonabsorbable, Silk | Class II | General and plastic surgery | Contract sterilization | Jan 28, 2013 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | Class II | General and plastic surgery | Contract sterilization | Jan 28, 2013 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract sterilization | Jan 28, 2013 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Mar 6, 2023 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Mar 28, 2025 |
| GEE | Brush, Biopsy, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Jan 28, 2013 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Jan 28, 2013 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract sterilization | Mar 10, 2023 |
| HAM | Apparatus, Electrosurgical | Class II | General and plastic surgery | Contract sterilization | Jan 29, 2013 |
| HGI | Electrocautery, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Jan 29, 2013 |
| HMX | Cannula, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Jan 28, 2013 |
| HNJ | Punch, Corneo-Scleral | Class I | Ophthalmic | Contract sterilization | Jan 28, 2013 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class I | Ophthalmic | Contract sterilization | Jan 29, 2013 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | Class II | Ophthalmic | Contract sterilization | Jan 29, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Jan 29, 2013 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | May 30, 2023 |
| HST | Apparatus, Traction, Non-Powered | Class I | Orthopedic | Contract sterilization | Aug 5, 2025 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Jan 29, 2013 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | May 30, 2023 |
| HWQ | Passer | Class I | Orthopedic | Contract sterilization | Jan 22, 2016 |
| HXK | Holder, Needle; Orthopedic | Class I | Orthopedic | Contract sterilization | Jan 5, 2024 |
| HXX | Screwdriver | Class I | Orthopedic | Contract sterilization | Jan 21, 2016 |
| IKD | Cable, Electrode | Class II | Physical medicine | Contract sterilization | Jan 30, 2013 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract sterilization | Jan 28, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| JOS | Electrode, Electrosurgical | Class II | General and plastic surgery | Contract sterilization | Jan 29, 2013 |
| JOW | Sleeve, Limb, Compressible | Class II | Cardiovascular | Contract sterilization | Jan 29, 2013 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Oct 14, 2015 |
| JYS | Perforator, Ear-Lobe | Class I | Ear, nose and throat | Contract sterilization | Mar 27, 2015 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract sterilization | May 6, 2024 |
| KGE | Forceps, Biopsy, Electric | Class II | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| KGS | Retention Device, Suture | Class I | General and plastic surgery | Contract sterilization | Jan 28, 2013 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract sterilization | Dec 29, 2008 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Class II | Obstetrics and gynecology | Contract sterilization | Jan 29, 2013 |
| KNG | Monitor, Ultrasonic, Fetal | Class II | Obstetrics and gynecology | Contract sterilization | Jan 28, 2013 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class II | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| KPE | Container, I.V. | Class II | General hospital | Contract sterilization | Jul 28, 2023 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | May 30, 2023 |
| KYX | Dispenser, Liquid Medication | Class I | General hospital | Contract sterilization | Jul 28, 2023 |
| LDF | Electrode, Pacemaker, Temporary | Class II | Cardiovascular | Contract sterilization | Jan 30, 2013 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract sterilization | Jul 28, 2023 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| LRC | Instrument, Ent Manual Surgical | Class I | Ear, nose and throat | Contract sterilization | May 31, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract sterilization | May 30, 2023 |
| LYS | Bone Mill | Class I | Orthopedic | Contract sterilization | Jul 19, 2023 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract sterilization | May 30, 2023 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Oct 14, 2015 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| MCZ | Suture Removal Kit | Class I | General and plastic surgery | Contract sterilization | Apr 8, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract sterilization | Jun 1, 2023 |
| MNU | Staple, Absorbable | Class II | Orthopedic | Contract sterilization | Jan 28, 2013 |
| NAC | Dressing, Wound, Hydrophilic | Class I | General and plastic surgery | Contract sterilization | Dec 13, 2021 |
| NAD | Dressing, Wound, Occlusive | Class I | General and plastic surgery | Contract sterilization | Dec 13, 2021 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract sterilization | Jan 21, 2016 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | Class II | General and plastic surgery | Contract sterilization | Feb 18, 2019 |
| NDN | Cement, Bone, Vertebroplasty | Class II | Orthopedic | Contract sterilization | May 31, 2023 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Class I | Orthopedic | Contract sterilization | May 31, 2023 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Class II | Gastroenterology and urology | Contract sterilization | Jan 28, 2013 |
| OFT | Spinal Epidural Anesthesia Kit | Class II | Anesthesiology | Contract sterilization | Apr 22, 2024 |
| OFU | Spinal Anesthesia Kit | Class II | Anesthesiology | Contract sterilization | Apr 22, 2024 |
| OGD | Custom Anesthesia Tray | Class II | Anesthesiology | Contract sterilization | Apr 22, 2024 |
| OGE | Epidural Anesthesia Kit | Class II | Anesthesiology | Contract sterilization | Apr 22, 2024 |
| OGJ | Nerve Block Tray | Class II | Anesthesiology | Contract sterilization | May 6, 2024 |
| OIL | Discography Kit | Class II | Radiology | Contract sterilization | Apr 18, 2024 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract sterilization | May 30, 2023 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | Class II | General and plastic surgery | Contract sterilization | Jul 13, 2023 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Mar 31, 2025 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology and urology | Contract sterilization | Aug 27, 2021 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Class II | Gastroenterology and urology | Contract sterilization | Jul 28, 2023 |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class II | Gastroenterology and urology | Contract sterilization | Dec 23, 2020 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | Class II | General hospital | Contract sterilization | May 6, 2024 |
| QEH | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | Class II | General hospital | Contract sterilization | Jul 28, 2023 |
| SCL | Allergen And Vaccine Delivery Needles | Class II | General hospital | Contract sterilization | Feb 28, 2023 |