FDA device listing
DRAPE,OPH,INCISE,40X48,W/PCH COVER,BACKTABLE,44"X75",SMS,EM
FDA device listing 1302891034 · Flextronics International USA, Inc.
Key facts
| Proprietary names | DRAPE,OPH,INCISE,40X48,W/PCH COVER,BACKTABLE,44"X75",SMS,EM |
|---|---|
| Owner/operator | Flextronics International USA, Inc. |
| Owner/operator number | 9006592 |
| Product codes | HMT |
| Device names | HMT - Drape, Patient, Ophthalmic |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4370 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Flextronics Manufacturing Juarez S. DE R.L. DE C.V. |
| Establishment registrations | 3007344957 |
| FEI numbers | 3007344957 |
| Establishment operations | Foreign Exporter |
| 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