Catalog Number

0400750000

Brand Name

NA

Version/Model Number

0400750000

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

8b3ab379-9768-4e47-946f-490f2bdf87e9

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

34546540904189

Quantity per Package

10

Contains DI Package

04546540904188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack