Catalog Number

-

Brand Name

Critigear

Version/Model Number

HCGS0002

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"

-

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

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

96b229bd-4b6a-44fe-bc68-be840ab6f329

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

January 31, 2020

Package DI Number

20810012921019

Quantity per Package

4

Contains DI Package

10810012921012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case