Identity
- Trade Name
- O'Reilly Femoral Head Extractor Small EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Extractor EUDAMEDO'Reilly Femoral Head Extractor Small FDA UDI
- Model / Reference
- 3674 EUDAMEDFDA UDI
- Description
- O'Reilly Femoral Head Extractor Small FDA UDI
Identifiers
- Catalog Number
- 3674 FDA UDI
- Primary DI / UDI-DI
- 00840277120243 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOEXTRACT0188 EUDAMED
- Direct Marketing DI
- 00840277120243 EUDAMED
- FDA Product Code
- HWB FDA UDI
- EMDN Code
- L0921 NON-IMPLANTABLE ORTHOPAEDIC DEVICES EXTRACTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The O'Reilly Femoral Head Extractor Small is a medical device designed for the safe and efficient extraction of femoral head fragments. This instrument features advanced technology, ensuring accurate and reliable results in clinical settings. With its user-friendly design and robust construction, it makes it an ideal choice for healthcare professionals.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8402771INNOEXTRACT0188 | 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 f2044810-d239-44eb-b872-d7f8013a5f6e 61 fields · synced Jul 14, 2026
- FDA UDI 406fee03-8549-4b4c-a2a6-e07f42b65bc9 34 fields · synced May 30, 2026