FDA device listing
Arkis Subcutaneous Guidewire,CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters,Integra,Jarit,Loop…
FDA device listing 1671378273 · Integra LifeSciences Corporation
Key facts
| Proprietary names | Arkis Subcutaneous Guidewire,CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters,Integra,Jarit,Loop Canulator / Canulator,MicroFrance,Miltex,Padgett,Wing-Grip |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| 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 | Integra Canada ULC, Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, Integra LifeSciences Production Corporation, INTEGRA MICROFRANCE SAS, Jarit GmbH |
| Establishment registrations | 9680837, 3003418325, 3004608878, 3005809810, 3012507533, 3014334038 |
| FEI numbers | 3003249645, 3003418325, 3004608878, 3005809810, 3012507533, 3014334038 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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