Catalog Number

ZRUP3436Rx4+vig

Brand Name

Avaline Medical NJ LLC

Version/Model Number

ZRUP3436Rx4+vig

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 22, 2022

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYQ

Product Code Name

GARMENT, PROTECTIVE, FOR INCONTINENCE

Public Device Record Key

1eaa9c68-81f2-46cd-9889-f6aac812c423

Public Version Date

March 23, 2022

Public Version Number

3

DI Record Publish Date

December 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-