Identity
- Trade Name
- Universal Hip Extractor T-Handle EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Extractor EUDAMEDUniversal Hip Extractor T-Handle FDA UDI
- Model / Reference
- 3610-03-B EUDAMEDFDA UDI
- Description
- Universal Hip Extractor T-Handle FDA UDI
Identifiers
- Catalog Number
- 3610-03-B FDA UDI
- Primary DI / UDI-DI
- 00840277100344 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOEXTRACT0188 EUDAMED
- Direct Marketing DI
- 00840277100344 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 Universal Hip Extractor T-Handle is a high-quality, reliable medical device designed to assist in the extraction of hip tissue for orthopedic surgeries. With its sturdy construction and precise instrument design, it is an essential tool for surgeons and medical professionals. This device ensures accurate and safe surgical procedures by providing a stable and controlled environment for the extraction process.
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 b541e273-d820-4257-9c27-9340bff1d931 61 fields · synced Jul 18, 2026
- FDA UDI e91cc8a8-bc35-44c2-84e4-5721f70e6fc6 34 fields · synced May 30, 2026