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Velys

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
VELYS FDA UDI
Generic Name
Optical surgical navigation device tracking system FDA UDI
Device Name
VELYS Robotic-Assisted Solution SAW HANDPIECE FDA UDI
Model / Reference
4515-70-102 FDA UDI
Description
VELYS Robotic-Assisted Solution SAW HANDPIECE FDA UDI

Identifiers

Catalog Number
451570102 FDA UDI
Primary DI / UDI-DI
10603295519430 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Optical surgical navigation device tracking system 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Optical surgical navigation device tracking system

Velys by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI 41eb7b6c-7f81-4988-9cc7-30ef5f2969e2 36 fields · synced Jun 8, 2026