Identity
- Trade Name
- FlareHawk Interbody Fusion System EUDAMEDNA FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- Tall Dilator, FH7 Endo EUDAMEDFDA UDI
- Model / Reference
- CMP-01983 EUDAMEDFDA UDI
- Description
- Tall Dilator, FH7 Endo FDA UDI
Identifiers
- Catalog Number
- CMP-01983 FDA UDI
- Primary DI / UDI-DI
- 00840200403849 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840200403849 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0707020101 VALVE DILATORS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic-access dilator, 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-00840200403849 | 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 fbd0ecb0-f249-46f6-bd9d-4b0b0292efbd 61 fields · synced May 30, 2026
- FDA UDI 7b506524-201e-4f03-a785-85a5b6872f19 35 fields · synced May 30, 2026