Catalog Number

D8009-OTH

Brand Name

AMD-RITMED VERSAGOWN

Version/Model Number

D8009-OTH

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

258ea716-2e5d-4514-8cdc-1d9e0c9c4ff4

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 17, 2019

Package DI Number

20686864053648

Quantity per Package

5

Contains DI Package

10686864053641

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case