Catalog Number

-

Brand Name

TECHStyles Gown Back

Version/Model Number

13-405N

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"

Yes

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

af07557d-0664-46d9-a5f7-232d91ffb7f3

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

10612899134055

Quantity per Package

50

Contains DI Package

00612899134058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-