Contract sterilizerSynergy Health AST, LLC (Petaluma, CA)CaliforniaCardiovascularEar, nose and throatGeneral hospitalGeneral and plastic surgeryHematologyOrthopedicGastroenterology and urologyOphthalmicNeurologyClass IIClass IUnclassifiedClass III
Synergy Health AST, LLC
Contract sterilizer · Petaluma, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3012102437 (openFDA record; or search FDA's registration database)
- FEI number
- 3012102437
- 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
- 3200 Lakeville Hwy, Suite 120, Petaluma, CA 94954
- Contract listings
- 40 device listings, 26 product codes, first listed Nov 13, 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 |
|---|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract sterilization | Nov 13, 2012 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract sterilization | Nov 16, 2012 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Jan 29, 2024 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract sterilization | Jun 13, 2019 |
| GAD | Retractor | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | Class II | Hematology | Contract sterilization | Oct 30, 2024 |
| HWQ | Passer | Class I | Orthopedic | Contract sterilization | Nov 15, 2012 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | Gastroenterology and urology | Contract sterilization | Aug 22, 2024 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Jun 13, 2019 |
| KYG | Device, Irrigation, Ocular Surgery | Class I | Ophthalmic | Contract sterilization | Sep 29, 2023 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | Class II | Orthopedic | Contract sterilization | Jan 21, 2013 |
| MGB | Device, Hemostasis, Vascular | Class III | Cardiovascular | Contract sterilization | Nov 16, 2012 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | Class III | Cardiovascular | Contract sterilization | Nov 13, 2012 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Jan 21, 2013 |
| NBE | Sealant, Polymerizing | Class III | General and plastic surgery | Contract sterilization | Jul 26, 2017 |
| NQR | Sealant, Dural | Class III | Neurology | Contract sterilization | Aug 17, 2023 |
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | Class III | Cardiovascular | Contract sterilization | Nov 30, 2023 |
| OWO | Drug-Eluting Sinus Stent | Class III | Ear, nose and throat | Contract sterilization | Nov 16, 2012 |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | Class II | General and plastic surgery | Contract sterilization | Jun 13, 2019 |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | Class II | General and plastic surgery | Contract sterilization | Jun 13, 2019 |
| OXK | Mesh, Surgical, Collagen, Large Abdominal Wall Defects | Class II | General and plastic surgery | Contract sterilization | Jun 13, 2019 |
| PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | Class III | Gastroenterology and urology | Contract sterilization | Dec 31, 2019 |
| PPN | Percutaneous Catheter, Ultrasound | Class II | Cardiovascular | Contract sterilization | Jul 20, 2017 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | Class II | Cardiovascular | Contract sterilization | Nov 13, 2020 |
| QEZ | Aspiration Thrombectomy Catheter | Class II | Cardiovascular | Contract sterilization | Nov 13, 2012 |
| QMG | Shockwave Intravascular Lithotripsy System | Class III | Cardiovascular | Contract sterilization | Feb 25, 2021 |