Catalog Number

75670474

Brand Name

Promax Surgical Gown

Version/Model Number

75670474

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041540,K041540

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

4e1fcd75-0301-4b73-a4fd-a8ae83bab7f6

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-