← Back to catalogue
Global Enable
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2245-10-040Model Hand-Held Surgical Retractor, Reusable
Identity
- Trade Name
- GLOBAL ENABLE EUDAMEDFDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Hand-Held Surgical Retractor, Reusable EUDAMEDGLOBAL ENABLE EXPOSURE SET REVERSE HOHMAN FDA UDI
- Model / Reference
- Hand-Held Surgical Retractor, Reusable EUDAMED2245-10-040 EUDAMEDFDA UDI
- Description
- GLOBAL ENABLE EXPOSURE SET REVERSE HOHMAN FDA UDI
Identifiers
- Catalog Number
- 224510040 FDA UDI
- Primary DI / UDI-DI
- 10603295107842 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004168R EUDAMED
- Direct Marketing DI
- 10603295107842 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Global Enable by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0603295a004168R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 4f8d5c8f-53b6-4552-b0bd-92ec76bef68f 61 fields · synced Jul 25, 2026
- FDA UDI a0a090a5-c0b7-449d-a6a1-c383c3cc7815 35 fields · synced May 30, 2026