FDA device listing
Abyrx4508 (WH) - Abyrx Putty Applicator,Abyrx4508 (WH) - Abyrx Spatula,Acuderm1463 (WH,LS)…
FDA device listing 1291225379 · STERIS Corporation
Key facts
| Proprietary names | Abyrx4508 (WH) - Abyrx Putty Applicator,Abyrx4508 (WH) - Abyrx Spatula,Acuderm1463 (WH,LS) - Acu-Dispo-Ce,BeInnovative11045 (LN) - Rotolock Cord Management System,Design2052 (NR) - CTS Relief Kit,Etex2142 (NR) - Precision Cannula 150 mm,Hydrofera (NR, WH) - Instrument Wipe,PhoenixMed2991 (SP) - Instrument, manual, surgical, general use,PhoenixMed2991 (SP) - Various Instruments,Protech3048 (TM)… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | MDM |
| Device names | MDM - Instrument, Manual, Surgical, General Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Isomedix Operations, Inc, Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC., STERIS Applied Sterilization Technologies ULC |
| Establishment registrations | 1047843, 1220477, 1424263, 1450662, 2030624, 2032098, 2183744, 2245304, 9680143 |
| FEI numbers | 1047843, 1220477, 1450662, 2183744, 2245304, 3000206435, 3002807308, 3003015552, 3003058448 |
| 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