Catalog Number

00383030

Brand Name

VYGON

Version/Model Number

38.30.30

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"

-

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

1b7f689b-e118-49ca-bcbf-aaaf44ccb0fa

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 09, 2021

Package DI Number

33660812015319

Quantity per Package

20

Contains DI Package

03660812015318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box