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Bozeman Direct Anterior THA Femoral Elevator Medium
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6146
Identity
- Trade Name
- Bozeman Direct Anterior THA Femoral Elevator Medium EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Retractor EUDAMEDBozeman Anterior THA Femoral Elevator Medium FDA UDI
- Model / Reference
- 6146 EUDAMEDFDA UDI
- Description
- Bozeman Anterior THA Femoral Elevator Medium FDA UDI
Identifiers
- Catalog Number
- 6146 FDA UDI
- Primary DI / UDI-DI
- 00840277111845 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNORETRACT016A EUDAMED
- Direct Marketing DI
- 00840277111845 EUDAMED
- FDA Product Code
- HTE FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bozeman Direct Anterior THA Femoral Elevator Medium by Innomed, 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 | 8402771INNORETRACT016A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED d9ac5988-ffcc-4d06-9ae0-57843915b0de 61 fields · synced Jul 10, 2026
- FDA UDI 26f9dd92-cd95-4fef-9908-8b6529ad3049 34 fields · synced May 29, 2026