Catalog Number

-

Brand Name

NA

Version/Model Number

1222-125S

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

327b442d-0ebd-4325-8cf0-aa9ef0165684

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

August 18, 2017

Package DI Number

10849296000731

Quantity per Package

35

Contains DI Package

00849296000734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-