Catalog Number

9604UK

Brand Name

Microtek™

Version/Model Number

9604UK

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

2bfa4204-d220-4a40-ba92-cbcf5192dc52

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

30748426074946

Quantity per Package

25

Contains DI Package

00748426074945

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-