Catalog Number

-

Brand Name

Cranberry

Version/Model Number

CR3028

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OPC

Product Code Name

Powder-Free Polychloroprene Patient Examination Glove

Public Device Record Key

a2e3ce18-5898-4d15-bb1b-ebdca7858107

Public Version Date

June 22, 2022

Public Version Number

4

DI Record Publish Date

December 09, 2021

Package DI Number

20817508021949

Quantity per Package

10

Contains DI Package

10817508021942

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case