FDA device listing
23G Asymmetrical Forceps REFLEX DSP,23G Endgrasping Forceps REFLEX DSP,23G GRIESHABER MAXGrip™ Forceps REFLEX DSP,23G…
FDA device listing 1547133705 · Sotera Health LLC
Key facts
| Proprietary names | 23G Asymmetrical Forceps REFLEX DSP,23G Endgrasping Forceps REFLEX DSP,23G GRIESHABER MAXGrip™ Forceps REFLEX DSP,23G ILM Forceps REFLEX DSP,23G Serrated Forceps REFLEX DSP,23G SHARKSKIN™ ILM Forceps DSP,23G SHARKSKIN™ ILM Forceps REFLEX DSP,25+™ Advanced DSP Tip Asymmetrical Forceps,25+™ Advanced DSP Tip Endgrasping Forceps,25+™ Advanced DSP Tip ILM Forceps,25+™ Advanced DSP Tip Serrated… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HNR |
| Device names | HNR - Forceps, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics Germany GmbH, Sterigenics Italy SpA, Sterigenics U.S. LLC, Sterigenics U.S., LLC |
| Establishment registrations | 1036836, 1054811, 2029275, 2953359, 3002807090, 3005941719, 3010407203 |
| FEI numbers | 1036836, 1000114185, 1000306431, 3000215205, 3002807111, 3006003617, 3010407203 |
| 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