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

ca4ad55c-3450-401f-9eed-d31ee8c840e0

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

November 04, 2016

Package DI Number

30748426063537

Quantity per Package

12

Contains DI Package

00748426063536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-