Catalog Number

8840UBC-SC

Brand Name

UBC

Version/Model Number

STD W/IN TN/PK 4"

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

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

8db4b67f-6ee2-448d-ac12-37444c206a03

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 05, 2022

Package DI Number

00724004619883

Quantity per Package

8

Contains DI Package

10724004619880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case