Men's Liberty - Men's Liberty 10-Pack Australia - BIODERM, INC.

Duns Number:114773653

Device Description: Men's Liberty 10-Pack Australia

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More Product Details

Catalog Number

-

Brand Name

Men's Liberty

Version/Model Number

23046-10AU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NOA

Product Code Name

Device, Paste-On For Incontinence, Non-Sterile

Device Record Status

Public Device Record Key

5490392c-150a-463a-b3a3-24ac95d13ce0

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 04, 2022

Additional Identifiers

Package DI Number

10653599001810

Quantity per Package

10

Contains DI Package

00653599001813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"BIODERM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84