Catalog Number

AU-1008S

Brand Name

Clear Horizon

Version/Model Number

AU-1008S

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

K061422,K061422

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

8f1f3aff-fb53-46da-bc2d-5af1e41fcf0f

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

December 09, 2016

Package DI Number

10866001000329

Quantity per Package

120

Contains DI Package

00866001000322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case