Identity
- Trade Name
- FlareHawk Interbody Fusion System EUDAMEDN/A FDA UDI
- Generic Name
- Arthroscopic access cannula, reusable FDA UDI
- Device Name
- Working Tube Dilator, FH7 EUDAMEDFDA UDI
- Model / Reference
- CMP-01188 EUDAMEDFDA UDI
- Description
- Working Tube Dilator, FH7 FDA UDI
Identifiers
- Catalog Number
- CMP-01188 FDA UDI
- Primary DI / UDI-DI
- 00810004728783 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810004728783 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1907 ARTHROSCOPIC SURGERY CANNULAS, REUSABLE EUDAMED
- GMDN Term
- Arthroscopic access cannula, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Yes
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-00810004728783 | 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 415d15fa-711c-495a-975f-46548535144f 61 fields · synced Jul 13, 2026
- FDA UDI c691afc4-5b6c-4e98-9286-61b677add3cb 35 fields · synced May 30, 2026