Identity
- Trade Name
- Straight pincer broach handle EUDAMEDHIP Instruments FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Hip Broach handle EUDAMEDStraight pincer broach handle FDA UDI
- Model / Reference
- 01.39.10.0024 EUDAMEDFDA UDI
- Description
- Straight pincer broach handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630040763752 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274HSR0381N00A9 EUDAMED
- Direct Marketing DI
- 07630040763752 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Italy 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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
HIP Instruments by Medacta International — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medacta International
Sources (2)
- FDA UDI e66d1e82-f1b4-4aa9-8fec-69fba52096e2 33 fields · synced Oct 8, 2026
- EUDAMED 3da4bfdd-aa89-43f9-a969-8f9cec07f1e8 61 fields · synced Oct 8, 2026