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

d6881967-4c0a-4b84-8316-c3fd2ccd3859

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

November 16, 2016

Package DI Number

30748426119463

Quantity per Package

25

Contains DI Package

00748426119462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-