Catalog Number

Au-10-143S

Brand Name

Austin

Version/Model Number

Au-10-143S

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

K061422,K061422

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

1d74285e-e023-4e05-925b-ba686b23db4a

Public Version Date

July 09, 2018

Public Version Number

1

DI Record Publish Date

June 08, 2018

Package DI Number

00866001000346

Quantity per Package

8

Contains DI Package

00866001000339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case