FDA device listing
Anodyne3068 (LN, LS) - PEYMAN,BVI1689 (EP1) - Anterior Chamber Cannula [Rycroft],BVI1689 (EP1) - Cortical Cleaving…
FDA device listing 1524600583 · STERIS Corporation
Key facts
| Proprietary names | Anodyne3068 (LN, LS) - PEYMAN,BVI1689 (EP1) - Anterior Chamber Cannula [Rycroft],BVI1689 (EP1) - Cortical Cleaving Hydrodissector,BVI1689 (EP1) - Flexible Tip Cannula,BVI1689 (EP1) - Infusion Cannulas,BVI1689 (EP1) - Irrigating Cystotome,BVI1689 (EP1) - Lacrimal Cannula,BVI1689 (EP1) - LASIK Irrigating Cannula,BVI1689 (EP1) - Micro J Shape Cannula,BVI1689 (EP1) - Soft Tip Cannula,BVI1689 (EP1)… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | HMX |
| Device names | HMX - Cannula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | Isomedix Operations, Inc, Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC, ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 1047843, 1319660, 1424263, 1450662, 1526711, 1643817, 1720929, 2030624, 2032098 |
| FEI numbers | 1047843, 1450662, 1526711, 1643817, 1720929, 1000136478, 3000206435, 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