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

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

93d37e30-d63f-4938-b77d-27007e188c09

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

January 19, 2017

Package DI Number

50748426092203

Quantity per Package

20

Contains DI Package

00748426092208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-