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

K910515,K910515

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

f7777df2-a962-4857-ada9-27c7f07630ae

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 26, 2016

Package DI Number

50748426091602

Quantity per Package

12

Contains DI Package

00748426091607

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-