Contract manufacturerContract sterilizerCOOK INCORPORATED (Ellettsville, IN)IndianaAnesthesiologyCardiovascularEar, nose and throatGastroenterology and urologyGeneral and plastic surgeryNeurologyRadiologyGeneral hospitalObstetrics and gynecologyDentalOphthalmicClass IIClass IUnclassified
COOK INCORPORATED
Contract manufacturer and sterilizer · Ellettsville, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1000393132 (openFDA record; or search FDA's registration database)
- FEI number
- 1000393132
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer; Contract manufacturer; Contract sterilizer
- Owner or operator
- COOK, INC. (FDA owner/operator no. 1820334)
- Registered address
- 6300 N. MATTHEWS DR., Ellettsville, IN 47429
- Contract listings
- 121 device listings, 77 product codes, first listed Dec 12, 1992
- 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 |
|---|---|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Class II | Anesthesiology | Contract sterilization | Dec 24, 2018 |
| BTR | Tube, Tracheal (W/Wo Connector) | Class II | Anesthesiology | Contract sterilization | May 28, 2019 |
| BWC | Needle, Emergency Airway | Class II | Anesthesiology | Contract sterilization | Jun 26, 2019 |
| DPW | Flowmeter, Blood, Cardiovascular | Class II | Cardiovascular | Contract manufacturing | Mar 5, 2014 |
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract sterilization | Feb 4, 2013 |
| DRB | Stylet, Catheter | Class II | Cardiovascular | Contract sterilization | Jan 15, 2020 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | Cardiovascular | Contract sterilization | Feb 4, 2013 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract sterilization | Feb 4, 2013 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Jan 28, 2020 |
| DXE | Catheter, Embolectomy | Class II | Cardiovascular | Contract sterilization | Feb 4, 2013 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | Class II | Cardiovascular | Contract sterilization | Sep 4, 2014 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract sterilization | May 24, 2018 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract sterilization | Oct 30, 2019 |
| EYB | Catheter, Ureteral, Gastro-Urology | Class II | Gastroenterology and urology | Contract sterilization | Aug 28, 2019 |
| EZN | Dilator, Catheter, Ureteral | Class II | Gastroenterology and urology | Contract sterilization | Dec 24, 2018 |
| FAD | Stent, Ureteral | Class II | Gastroenterology and urology | Contract sterilization | May 13, 2019 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract sterilization | Sep 9, 2019 |
| FCG | Biopsy Needle | Class II | Gastroenterology and urology | Contract sterilization | Dec 22, 2017 |
| FDI | Snare, Flexible | Class II | Gastroenterology and urology | Contract sterilization | Dec 3, 2019 |
| FDX | Endoscopic Cytology Brush | Class II | Gastroenterology and urology | Contract sterilization | Jan 15, 2018 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract sterilization | Aug 29, 2019 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Class II | Gastroenterology and urology | Contract sterilization | Dec 12, 1992 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology and urology | Contract manufacturing | May 21, 2018 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology and urology | Contract sterilization | Feb 4, 2013 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract sterilization | Feb 4, 2013 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract sterilization | Nov 19, 2007 |
| GAH | Stylet, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Feb 5, 2013 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract sterilization | Jan 6, 2017 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Class II | Gastroenterology and urology | Contract sterilization | Feb 4, 2013 |
| GCC | Dilator, Catheter | Class I | General and plastic surgery | Contract sterilization | Feb 4, 2013 |
| GCE | Adaptor, Catheter | Class I | General and plastic surgery | Contract sterilization | Jun 18, 2007 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract sterilization | Feb 26, 2019 |
| GXQ | Dura Substitute | Class II | Neurology | Contract sterilization | Feb 4, 2013 |
| HYA | Forceps, Wire Holding | Class I | General and plastic surgery | Contract sterilization | Feb 5, 2013 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | Mar 5, 2014 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract sterilization | Feb 4, 2013 |
| JOP | Transducer, Ultrasonic | Class II | Cardiovascular | Contract manufacturing | Mar 5, 2014 |
| JOP | Transducer, Ultrasonic | Class II | Cardiovascular | Contract sterilization | Feb 4, 2013 |
| JXI | Cuff, Nerve | Class II | Neurology | Contract sterilization | Feb 4, 2013 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract sterilization | Oct 25, 2004 |
| KGC | Tube, Gastro-Enterostomy | Class II | Gastroenterology and urology | Contract sterilization | Jul 12, 2019 |
| KGE | Forceps, Biopsy, Electric | Class II | Gastroenterology and urology | Contract sterilization | Aug 25, 2020 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Feb 4, 2013 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | Class II | Ear, nose and throat | Contract sterilization | Jun 1, 2016 |
| KNQ | Dilator, Esophageal | Class II | Gastroenterology and urology | Contract sterilization | Jan 27, 2016 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class II | Gastroenterology and urology | Contract sterilization | Feb 4, 2013 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Dec 24, 2018 |
| KOD | Catheter, Urological | Class II | Gastroenterology and urology | Contract sterilization | Jan 10, 2019 |
| KOE | Dilator, Urethral | Class II | Gastroenterology and urology | Contract sterilization | Dec 24, 2018 |
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract sterilization | Apr 11, 2019 |
| KRD | Device, Vascular, For Promoting Embolization | Class II | Cardiovascular | Contract sterilization | May 21, 2018 |
| KYZ | Syringe, Irrigating (Non Dental) | Class I | General hospital | Contract sterilization | Feb 23, 2012 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Class II | Cardiovascular | Contract sterilization | Dec 24, 2018 |
| LJE | Catheter, Nephrostomy | Unclassified | Gastroenterology and urology | Contract sterilization | Apr 2, 2019 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | Class II | General hospital | Contract manufacturing | Mar 10, 2014 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | Class II | General hospital | Contract sterilization | Nov 27, 2007 |
| LKF | Cannula, Manipulator/Injector, Uterine | Class II | Obstetrics and gynecology | Contract sterilization | Jan 8, 2019 |
| LQC | Lithotriptor, Biliary Mechanical | Class II | Gastroenterology and urology | Contract sterilization | Apr 8, 2021 |
| LQR | Dislodger, Stone, Biliary | Class II | Gastroenterology and urology | Contract sterilization | Mar 25, 2019 |
| LRW | Scissors, General, Surgical | Class I | General and plastic surgery | Contract sterilization | Feb 5, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract sterilization | Jan 21, 1997 |
| MQF | Catheter, Assisted Reproduction | Class II | Obstetrics and gynecology | Contract sterilization | Jan 8, 2019 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | Class II | Obstetrics and gynecology | Contract manufacturing | Mar 5, 2014 |
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | Class II | Obstetrics and gynecology | Contract sterilization | Jun 20, 2019 |
| NEU | Marker, Radiographic, Implantable | Class II | General and plastic surgery | Contract sterilization | Aug 29, 2024 |
| NPL | Barrier, Animal Source, Intraoral | Class II | Dental | Contract sterilization | Feb 4, 2013 |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | Class II | Ophthalmic | Contract sterilization | Feb 4, 2013 |
| OCX | Endoscopic Irrigation/Suction System | Class II | Gastroenterology and urology | Contract sterilization | Oct 30, 2019 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract sterilization | Feb 4, 2013 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology and urology | Contract sterilization | Aug 29, 2024 |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | Class II | Gastroenterology and urology | Contract sterilization | Mar 25, 2019 |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | Class II | General and plastic surgery | Contract sterilization | Feb 3, 2017 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | Class II | General and plastic surgery | Contract sterilization | Feb 4, 2013 |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | Class II | General and plastic surgery | Contract sterilization | Aug 24, 2020 |
| OXK | Mesh, Surgical, Collagen, Large Abdominal Wall Defects | Class II | General and plastic surgery | Contract sterilization | Aug 18, 2016 |
| OXN | Mesh, Surgical, Collagen, Fistula | Class II | General and plastic surgery | Contract sterilization | Aug 24, 2020 |
| PAG | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | Class II | General and plastic surgery | Contract sterilization | Feb 4, 2013 |
| PAJ | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | Class II | General and plastic surgery | Contract sterilization | Feb 4, 2013 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | Class II | Cardiovascular | Contract sterilization | Dec 14, 2018 |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class II | Gastroenterology and urology | Contract sterilization | Dec 22, 2017 |
| QCX | Retrograde Intubation Set | Class II | Anesthesiology | Contract sterilization | Feb 20, 2019 |