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

a36d9415-ce6c-467b-a58c-89e3bdf387f2

Public Version Date

February 06, 2020

Public Version Number

7

DI Record Publish Date

November 04, 2016

Package DI Number

50748426100175

Quantity per Package

2

Contains DI Package

30748426100171

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-