Faceplate Strip - Faceplate Strip (Pack of 450) - BIODERM, INC.

Duns Number:114773653

Device Description: Faceplate Strip (Pack of 450)

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More Product Details

Catalog Number

-

Brand Name

Faceplate Strip

Version/Model Number

20002NP

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

0485c2ba-78b4-43fb-8933-51742ae60973

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 05, 2020

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