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Global Unite
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2100-61-071Model Orthopaedic Prosthesis Implantation Instrument, Reusable
Identity
- Trade Name
- GLOBAL UNITE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Orthopaedic Prosthesis Implantation Instrument, Reusable EUDAMEDGLOBAL UNITE CUTTING GUIDE 128/142 DEGREE FDA UDI
- Model / Reference
- Orthopaedic Prosthesis Implantation Instrument, Reusable EUDAMED2100-61-071 EUDAMEDFDA UDI
- Description
- GLOBAL UNITE CUTTING GUIDE 128/142 DEGREE FDA UDI
Identifiers
- Catalog Number
- 210061071 FDA UDI
- Primary DI / UDI-DI
- 10603295430346 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004268U EUDAMED
- Direct Marketing DI
- 10603295430346 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant impactor, reusable
Global Unite 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 | 0603295a004268U | 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 5f14335c-b2f4-42c2-b011-38fa6dfb474a 61 fields · synced Jul 9, 2026
- FDA UDI a959b1a5-c786-46df-af38-3f6a65b565c5 35 fields · synced May 30, 2026