Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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"

-

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

K882724,K882724,K882724

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

a701918d-7788-4168-9db0-4fd7e292b912

Public Version Date

February 20, 2019

Public Version Number

5

DI Record Publish Date

January 17, 2017

Package DI Number

30748426119425

Quantity per Package

20

Contains DI Package

00748426119424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-