Catalog Number

4515-70-009

Brand Name

DePuy Synthes VELYS

Version/Model Number

451570009

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

af60eb74-1426-4189-8823-c517d77cb078

Public Version Date

April 12, 2021

Public Version Number

2

DI Record Publish Date

April 01, 2021

Package DI Number

50748426124904

Quantity per Package

20

Contains DI Package

00748426124909

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-