Catalog Number

8515

Brand Name

GAMMEX

Version/Model Number

8515

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

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

7852db53-82a6-4d06-b71d-9b01ae29779c

Public Version Date

February 15, 2022

Public Version Number

1

DI Record Publish Date

February 07, 2022

Package DI Number

20884792385149

Quantity per Package

50

Contains DI Package

00884792385145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser