Catalog Number

1280

Brand Name

Sterile Disposable System Drape Kit

Version/Model Number

1280

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K970885,K970891,K970885,K970891

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

d36fe279-5537-486d-97ea-f977eea1c4cd

Public Version Date

March 22, 2022

Public Version Number

6

DI Record Publish Date

November 17, 2017

Package DI Number

10841912105332

Quantity per Package

24

Contains DI Package

00841912105335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-