Catalog Number

N/A

Brand Name

BioButton Rechargeable Adhesives (ADD-HT)

Version/Model Number

ADH-AC1-BBR-5-1-1-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

cde0eba4-a345-46e8-8da1-9bdd06282fd3

Public Version Date

July 28, 2022

Public Version Number

1

DI Record Publish Date

July 20, 2022

Package DI Number

10850005949241

Quantity per Package

50

Contains DI Package

00850005949244

Package Discontinue Date

July 20, 2022

Package Status

Not in Commercial Distribution

Package Type

Inner Carton - 50x5