Men's Liberty Acute - Men's Liberty Acute with CathGrip and Towel - BIODERM, INC.

Duns Number:114773653

Device Description: Men's Liberty Acute with CathGrip and Towel

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More Product Details

Catalog Number

-

Brand Name

Men's Liberty Acute

Version/Model Number

BIO2102611

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

f1a00ed4-fe3d-4f5d-a7e5-0c3ee0df035f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 06, 2020

Additional Identifiers

Package DI Number

10653599000851

Quantity per Package

35

Contains DI Package

00653599000854

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