Catalog Number

-

Brand Name

Cranberry

Version/Model Number

CR3665

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

28c0b163-6a86-4fd4-9986-b1cb522736a9

Public Version Date

June 23, 2022

Public Version Number

4

DI Record Publish Date

December 15, 2021

Package DI Number

20817508020188

Quantity per Package

10

Contains DI Package

10817508020181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case