Catalog Number

GL500PFB

Brand Name

Dermatec Bronze Star

Version/Model Number

GL500PFB

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)

Yes

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

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

c2f072b3-92b9-4525-bee6-a704d4a17f84

Public Version Date

September 13, 2022

Public Version Number

1

DI Record Publish Date

September 05, 2022

Package DI Number

10813417020175

Quantity per Package

10

Contains DI Package

00813417020178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box