Identity
- Trade Name
- VELYS FDA UDI
- Generic Name
- Optical surgical navigation device tracking system FDA UDI
- Device Name
- VELYS Connectors EUDAMEDVELYS Robotic-Assisted Solution SAW INTERFACE CLEANING CAP FDA UDI
- Model / Reference
- 4515-70-226 EUDAMEDFDA UDI
- Description
- VELYS Robotic-Assisted Solution SAW INTERFACE CLEANING CAP FDA UDI
Identifiers
- Catalog Number
- 451570226 FDA UDI
- Primary DI / UDI-DI
- 10603295519935 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0029493 EUDAMED
- Direct Marketing DI
- 10603295519935 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VELYS Connectors 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 | 0603295a0029493 | 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 ad90f210-b3d4-4d43-bec0-7ac0fe3e1b01 61 fields · synced Jun 19, 2026
- FDA UDI 32ba73d9-66c7-4028-bcb6-54817ad32ad0 35 fields · synced May 30, 2026