Catalog Number

GWS-03-XXL-B

Brand Name

Texas Medical Technology

Version/Model Number

GWS-03-XXL-B

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)

Yes

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

a607e031-e1b1-49db-bd49-18cb35f5765a

Public Version Date

May 12, 2022

Public Version Number

8

DI Record Publish Date

February 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-