Catalog Number

A-AU-TT1-SG

Brand Name

Austin Medical

Version/Model Number

A-AU-TT1-SG

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)

-

Over the Counter (OTC)

Yes

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

714bd680-0d9b-4bcc-b160-10377442afcd

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

June 20, 2019

Package DI Number

00850003355481

Quantity per Package

14

Contains DI Package

00850003355474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case