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

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

caef0d31-7ac5-4a3f-98a3-8570fff4c5ee

Public Version Date

February 11, 2019

Public Version Number

3

DI Record Publish Date

November 04, 2016

Package DI Number

50748426090841

Quantity per Package

24

Contains DI Package

00748426090846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-