Catalog Number

A69958-C

Brand Name

RITMED ASSURE WEAR VERSAGOWN

Version/Model Number

A69958-C

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OEA

Product Code Name

Non-surgical isolation gown

Public Device Record Key

55d3f1bb-c802-4878-b3fa-9e7363babb2f

Public Version Date

May 22, 2020

Public Version Number

1

DI Record Publish Date

May 14, 2020

Package DI Number

20686864056427

Quantity per Package

10

Contains DI Package

10686864056420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-