Contract sterilizerSynergy Health AST, LLC (Saxonburg, PA)PennsylvaniaCardiovascularGeneral and plastic surgeryGeneral hospitalHematologyRadiologyOrthopedicClinical chemistryObstetrics and gynecologyNeurologyClass IIClass IUnclassifiedClass III
Synergy Health AST, LLC
Contract sterilizer · Saxonburg, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009882464 (openFDA record; or search FDA's registration database)
- FEI number
- 3009882464
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract sterilizer
- Owner or operator
- Synergy Health AST, LLC (FDA owner/operator no. 10028672)
- Registered address
- 7225 N Noah Dr, Saxonburg, PA 16056
- Contract listings
- 60 device listings, 35 product codes, first listed Oct 31, 2012
- 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 |
|---|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract sterilization | Oct 31, 2012 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract sterilization | Dec 26, 2012 |
| FYD | Apparatus, Exhaust, Surgical | Class II | General and plastic surgery | Contract sterilization | Mar 1, 2013 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract sterilization | Feb 12, 2013 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Nov 19, 2024 |
| GGY | Pipette, Diluting | Class I | Hematology | Contract sterilization | Nov 15, 2012 |
| IZQ | Injector, Contrast Medium, Automatic | Class II | Cardiovascular | Contract sterilization | Oct 19, 2018 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Class II | Radiology | Contract sterilization | Oct 31, 2012 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | Class II | Orthopedic | Contract sterilization | Jan 21, 2013 |
| MDD | Device, Dermal Replacement | Class III | General and plastic surgery | Contract sterilization | Dec 30, 2015 |
| MDS | Sensor, Glucose, Invasive | Class III | Clinical chemistry | Contract sterilization | Sep 19, 2024 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unclassified | General and plastic surgery | Contract sterilization | Nov 25, 2024 |
| MGR | Dressing, Wound And Burn, Interactive | Class III | General and plastic surgery | Contract sterilization | Dec 30, 2015 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Jan 21, 2013 |
| MQX | Needle, Acupuncture, Single Use | Class II | General hospital | Contract sterilization | Sep 26, 2018 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract sterilization | Dec 5, 2015 |
| NAC | Dressing, Wound, Hydrophilic | Class I | General and plastic surgery | Contract sterilization | Jun 17, 2013 |
| NAD | Dressing, Wound, Occlusive | Class I | General and plastic surgery | Contract sterilization | Jun 17, 2013 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Class I | Obstetrics and gynecology | Contract sterilization | Mar 1, 2013 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Class II | Radiology | Contract sterilization | May 29, 2020 |
| NQR | Sealant, Dural | Class III | Neurology | Contract sterilization | Aug 17, 2023 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | Class II | General and plastic surgery | Contract sterilization | Nov 7, 2013 |
| ORD | Optical Coherence Tomography, Intravascular Catheter | Class II | Cardiovascular | Contract sterilization | May 29, 2020 |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | Class II | General and plastic surgery | Contract sterilization | Jun 13, 2019 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract sterilization | Dec 26, 2012 |
| OXB | Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | Class II | General and plastic surgery | Contract sterilization | Dec 26, 2012 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | Class II | General and plastic surgery | Contract sterilization | Dec 26, 2012 |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | Class II | General and plastic surgery | Contract sterilization | Dec 26, 2012 |
| OXK | Mesh, Surgical, Collagen, Large Abdominal Wall Defects | Class II | General and plastic surgery | Contract sterilization | Dec 5, 2015 |
| OZP | Automated Insulin Dosing Device System, Single Hormonal Control | Class III | Clinical chemistry | Contract sterilization | Sep 19, 2024 |
| PAJ | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | Class II | General and plastic surgery | Contract sterilization | Dec 26, 2012 |
| PDU | Catheter For Crossing Total Occlusions | Class II | Cardiovascular | Contract sterilization | Aug 31, 2016 |
| PQF | Sensor, Glucose, Invasive, Non-Adjunctive | Class III | Clinical chemistry | Contract sterilization | Sep 19, 2024 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | Class II | Cardiovascular | Contract sterilization | Nov 13, 2020 |