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

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

13b490e2-ca15-4a5d-8cbb-3a1f7d4aa6c3

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

November 04, 2016

Package DI Number

50748426113144

Quantity per Package

10

Contains DI Package

00748426113149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-