Identity
- Trade Name
- VELYS FDA UDI
- Generic Name
- Stereotactic surgery system probe, single-use FDA UDI
- Device Name
- VELYS Robotic-Assisted Solution ARRAY FULL SET KNEE FDA UDI
- Model / Reference
- 4515-70-203 FDA UDI
- Description
- VELYS Robotic-Assisted Solution ARRAY FULL SET KNEE FDA UDI
Identifiers
- Catalog Number
- 451570203 FDA UDI
- Primary DI / UDI-DI
- 10603295537984 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Stereotactic surgery system probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Stereotactic surgery system probe, single-use
Velys by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (1)
- FDA UDI 960cf5d8-68e1-41e5-b5f6-1e016d061434 35 fields · synced May 29, 2026