Catalog Number

E104160

Brand Name

POSS

Version/Model Number

00401

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120045,K120045

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

8c35da78-36c4-403f-b1fa-0116fc6e283d

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

March 26, 2020

Package DI Number

00850337007308

Quantity per Package

28

Contains DI Package

00850337007292

Package Discontinue Date

March 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Case