Identity
- Trade Name
- VELYS FDA UDI
- Generic Name
- Screwing power tool attachment FDA UDI
- Device Name
- VELYS Powertool Attachments EUDAMEDVELYS Robotic-Assisted Solution ARRAY DRILL PIN INSERTER FDA UDI
- Model / Reference
- 4515-70-108 EUDAMEDFDA UDI
- Description
- VELYS Robotic-Assisted Solution ARRAY DRILL PIN INSERTER FDA UDI
Identifiers
- Catalog Number
- 451570108 FDA UDI
- Primary DI / UDI-DI
- 10603295519386 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a002938Z EUDAMED
- Direct Marketing DI
- 10603295519386 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Screwing power tool attachment 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
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-purpose stereotactic surgery system
VELYS Powertool Attachments 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 | 0603295a002938Z | 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 2e0aedc1-54ab-449c-92e7-b38cce47b06e 61 fields · synced Jun 18, 2026
- FDA UDI 25fc1d49-0189-4962-b773-96e0d4849b2e 35 fields · synced May 29, 2026