Catalog Number

A800-0310

Brand Name

Austin Medical, Inc.

Version/Model Number

A800-0310

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

10bf9bdf-48fd-40b3-b534-81a2d1f72987

Public Version Date

January 18, 2022

Public Version Number

2

DI Record Publish Date

January 05, 2022

Package DI Number

00850017635456

Quantity per Package

25

Contains DI Package

00866001000391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case