Catalog Number

HemviewCSD01

Brand Name

Austin Medical, Inc.

Version/Model Number

HemviewCSD01

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

K121919,K121919

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

d86a5d00-ab6f-4f9a-ae2f-3818b8c14c3d

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

December 09, 2021

Package DI Number

00866001000360

Quantity per Package

10

Contains DI Package

00866001000353

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case