FDA device listing
Helistat Absorbable Collagen Hemostatic Sponge,Helitene Absorbable Collagen Hemostatic Agent,OraFOAM Absorbable Collagen…
FDA device listing 1773461133 · Integra LifeSciences Corporation
Key facts
| Proprietary names | Helistat Absorbable Collagen Hemostatic Sponge,Helitene Absorbable Collagen Hemostatic Agent,OraFOAM Absorbable Collagen Hemostatic Sponge |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| Premarket submissions | P850010 |
| Product codes | LMF |
| Device names | LMF - Agent, Absorbable Hemostatic, Collagen Based |
| Device class | Class III |
| Classification regulations (21 CFR) | 878.4490 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, INTEGRA NEUROSCIENCES |
| Establishment registrations | 1121308, 2648988, 3003418325 |
| FEI numbers | 1121308, 3000204775, 3003418325 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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