Men's Liberty - Faceplate Seal for iMEDicare (pack of 10) - BIODERM, INC.

Duns Number:114773653

Device Description: Faceplate Seal for iMEDicare (pack of 10)

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More Product Details

Catalog Number

-

Brand Name

Men's Liberty

Version/Model Number

20002UK

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

58a9fdad-32c1-4883-8508-9b314b76b4a3

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

July 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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