Catalog Number

-

Brand Name

NA

Version/Model Number

1224-BB3012

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

a783743b-5567-4b0f-bf4f-7518a91827cc

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

June 14, 2017

Package DI Number

10849296000113

Quantity per Package

25

Contains DI Package

00849296000116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-