FDA device listing
ACCURIS HANDSAGEBLATT 15X135,ACCURIS-TIBIAL INLAY CUTTER,General Surgical Instrument,GII SAGEBLATT AMSCO/HALL,GII…
FDA device listing 1226622099 · Sotera Health LLC
Key facts
| Proprietary names | ACCURIS HANDSAGEBLATT 15X135,ACCURIS-TIBIAL INLAY CUTTER,General Surgical Instrument,GII SAGEBLATT AMSCO/HALL,GII SAGEBLATT DE SOUTTER,GII SAGEBLATT LINVATEC/HALL,GII SAGEBLATT STRYKER,GII SAGEBLATT STRYKER-NEU,GII SAGEB.LINVATEC/HALL SCHMAL,GII SAWBL.3/4 IN.MICRO-AIRE,GII SAWBLADE STRYKER S6 3/4 IN.,GII SAWBLADE STRYKER S6 NARROW,GII SAWBLADE STRYKER S6 WIDE,GII SMALL 3M SAWBLADE,GII SM OLD… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GEY |
| Device names | GEY - Motor, Surgical Instrument, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1054811, 2029275, 3002907620 |
| FEI numbers | 1000114185, 1000306431, 3002907620 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database