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Reclaim
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2975-00-645Model RECLAIM Implant Handling Inserter/Introducer, Hip
Identity
- Trade Name
- RECLAIM EUDAMEDFDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Device Name
- Implant Handling Inserter/Introducer, Hip EUDAMEDRECLAIM ASSEMBLY TENSILE BAR FDA UDI
- Model / Reference
- RECLAIM Implant Handling Inserter/Introducer, Hip EUDAMED2975-00-645 EUDAMEDFDA UDI
- Description
- RECLAIM ASSEMBLY TENSILE BAR FDA UDI
Identifiers
- Catalog Number
- 297500645 FDA UDI
- Primary DI / UDI-DI
- 10603295156031 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005869K EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Joint prosthesis implantation kit, single-use
Reclaim by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0603295a005869K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED b8b214e1-1baf-40c6-9113-7a9d149ec38c 61 fields · synced Jul 10, 2026
- FDA UDI eece0f09-b1cb-4daa-961e-0633d27e1a14 35 fields · synced May 30, 2026