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Depuy Synthes
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1172-30-000Model DEPUY SYNTHES Cancellous Bone Screw
Identity
- Trade Name
- DEPUY SYNTHES EUDAMEDNA FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Cancellous Bone Screw EUDAMEDCANCELLOUS BONE SCREW 6.5mm x 30mm FDA UDI
- Model / Reference
- DEPUY SYNTHES Cancellous Bone Screw EUDAMED1172-30-000 EUDAMEDFDA UDI
- Description
- CANCELLOUS BONE SCREW 6.5mm x 30mm FDA UDI
Identifiers
- Catalog Number
- 117230000 FDA UDI
- Primary DI / UDI-DI
- 10603295007623 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004108D EUDAMED
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120602 CANCELLOUS SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 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
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Depuy Synthes by DePuy Ireland UC — Class IIb — 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 | 0603295a004108D | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 92da3779-cdea-428c-87da-1b08d57c3a12 61 fields · synced Jul 9, 2026
- FDA UDI b5b62a72-0bf6-41ef-a2f0-3dcec3ee9fcf 35 fields · synced May 30, 2026