FDA device listing
Integra,Jarit,MicroFrance,Miltex
FDA device listing 1323337764 · Integra LifeSciences Corporation
Key facts
| Proprietary names | Integra,Jarit,MicroFrance,Miltex |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| Product codes | FTX |
| Device names | FTX - Mirror, General & Plastic Surgery |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, Jarit GmbH |
| Establishment registrations | 3003418325, 3004608878, 3005809810 |
| FEI numbers | 3003418325, 3004608878, 3005809810 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| 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