Catalog Number

-

Brand Name

Cranberry

Version/Model Number

CR3440_SP

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

K092472,K092472,K092472

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

340995d6-639b-4271-a12e-3885480f7df6

Public Version Date

June 16, 2022

Public Version Number

2

DI Record Publish Date

May 24, 2022

Package DI Number

20817508023745

Quantity per Package

100

Contains DI Package

10817508023748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case