FlareHawk II-1-0146
FlareHawk II-1-0146 is a Class I device made by Integrity Implants Inc., listed in FDA GUDID since 22 Aug 2016 (UDI-DI 00850231007138), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850231007138 | Date22 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00850231007138
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- FlareHawk
- Generic name
- Instrument tray, reusable
- Model / Ref / Catalog
- II-1-0146
- Primary DI / UDI-DI
- 00850231007138
- FDA product code
- FSM
- GMDN term
- Instrument tray, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Instrument tray, reusable.
- PST Corp. 1321A by Plastic Sterilizing Tray Corporation
- Stryker Universal Select Sterilization Tray System by Paragon Medical Inc.
- PST Corp. 2526S by Plastic Sterilizing Tray Corporation
- APEX Knee System WS-60018 by OMNIlife science, Inc.
- The Hinge Pediatric Plating System HPDG110 by ORTHOPEDIATRICS CANADA ULC
- INSTRUSAFE IN-2600-04-EN-009 by Summit Medical, LLC
- APEX Knee System KS-99020 by OMNIlife science, Inc.
- Fix Konisch Surgical Tray FK6301 by MEDIGMA BIOMEDICAL GMBH