Catalog Number

-

Brand Name

NA

Version/Model Number

1222-8717

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070432,K070432

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

86c21769-d7f9-4b4b-934d-54434184b8d7

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

June 14, 2017

Package DI Number

10849296003640

Quantity per Package

30

Contains DI Package

00849296003643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-