Identity
- Trade Name
- FlareHawk Interbody Fusion System EUDAMEDFlareHawk FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Gun Inserter, Long EUDAMEDFDA UDI
- Model / Reference
- ASY-00004 EUDAMEDFDA UDI
- Description
- Gun Inserter, Long FDA UDI
Identifiers
- Catalog Number
- ASY-00004 FDA UDI
- Primary DI / UDI-DI
- 00818613020953 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00818613020953 EUDAMED
- 510(k) Number
- K160076 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- L091106 INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
FlareHawk Interbody Fusion System by Integrity Implants Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00818613020953 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Integrity Implants Inc.
- EUDAMED SRN
- US-MF-000009805
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0f48b679-a428-4b59-996b-2c423bc3e698 61 fields · synced Jul 8, 2026
- FDA UDI 5f9cea13-f985-4102-9ef1-64bba579a2af 36 fields · synced May 30, 2026