Catalog Number

-

Brand Name

BGEcare Elastic Bandage with Self-closure

Version/Model Number

EB070205011206NS

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FQM

Product Code Name

Bandage, Elastic

Public Device Record Key

804757f4-3072-4403-ad63-aa0f9df364f6

Public Version Date

September 20, 2021

Public Version Number

2

DI Record Publish Date

March 08, 2021

Package DI Number

06972403420010

Quantity per Package

6

Contains DI Package

06972403420003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box