GLOBAL ICON Stemless Shoulder System
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- GLOBAL ICON Stemless Shoulder System EUDAMEDGLOBAL ICON FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Orthopaedic Prosthesis Implantation Instrument, Reusable EUDAMEDGLOBAL ICON Stemless Shoulder System HUMERAL PREP GUIDE Size 40 FDA UDI
- Model / Reference
- Orthopaedic Prosthesis Implantation Instrument, Reusable EUDAMED2240-11-040 EUDAMEDFDA UDI
- Description
- GLOBAL ICON Stemless Shoulder System HUMERAL PREP GUIDE Size 40 FDA UDI
Identifiers
- Catalog Number
- 224011040 FDA UDI
- Primary DI / UDI-DI
- 10603295427032 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004268U EUDAMED
- Direct Marketing DI
- 10603295427032 EUDAMED
- FDA Product Code
- PKC 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic implant impactor, reusable
GLOBAL ICON Stemless Shoulder System 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
CE/MDR
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 663f99ed-93de-46eb-bd23-b69001ee2b26 61 fields · synced Jul 10, 2026
- FDA UDI 6295258f-79cf-4746-a1f9-e0d3d36167d8 35 fields · synced May 30, 2026