Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

10278

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)

-

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

c75cffc9-72c7-412d-927a-56fcfe70e1e3

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 24, 2021

Package DI Number

60368001102782

Quantity per Package

12

Contains DI Package

00368001102780

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case