Catalog Number

3436Rx10+vig

Brand Name

Avaline Medical NJ LLC

Version/Model Number

3436Rx10+vig

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)

-

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

73ce8b40-405d-451b-b677-f2b1bff6770b

Public Version Date

March 30, 2022

Public Version Number

1

DI Record Publish Date

March 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-