Men's Liberty Acute - Men's Liberty Acute without CathGrip - BIODERM, INC.

Duns Number:114773653

Device Description: Men's Liberty Acute without CathGrip

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More Product Details

Catalog Number

-

Brand Name

Men's Liberty Acute

Version/Model Number

BIO210268

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

7d2be960-cd23-42d9-a2b8-f1a04155c17f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 02, 2020

Additional Identifiers

Package DI Number

10653599000875

Quantity per Package

35

Contains DI Package

00653599000878

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