Identity
- Trade Name
- Dilator Impactor, FH7 MIS EUDAMEDN/A FDA UDI
- Generic Name
- Orthopaedic implantation hammering attachment FDA UDI
- Device Name
- FlareHawk Dilator Impactors EUDAMEDDILATOR IMPACTOR, FH7 MIS FDA UDI
- Model / Reference
- CMP-00480 EUDAMEDFDA UDI
- Description
- DILATOR IMPACTOR, FH7 MIS FDA UDI
Identifiers
- Catalog Number
- CMP-00480 FDA UDI
- Primary DI / UDI-DI
- 00810004722002 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081000472INSTMANACCESSMV EUDAMED
- Direct Marketing DI
- 00810004722002 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implantation hammering attachment 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Dilator Impactor, FH7 MIS by Integrity Implants Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081000472INSTMANACCESSMV | 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 14d04821-a286-470b-ba01-afd423d723ea 61 fields · synced Jul 16, 2026
- FDA UDI 6e36422e-cb44-4dd1-bca6-2e519a1d1fd6 35 fields · synced May 25, 2026