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

c0222016-75e9-4643-b33f-485fa6f13a12

Public Version Date

February 06, 2020

Public Version Number

5

DI Record Publish Date

December 26, 2016

Package DI Number

50748426110617

Quantity per Package

20

Contains DI Package

00748426110612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-