Criterion CR Chloroprene Glove - Criterion CR Chloroprene Glove Medium - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Criterion CR Chloroprene Glove Medium

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More Product Details

Catalog Number

1126859

Brand Name

Criterion CR Chloroprene Glove

Version/Model Number

1126859

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

LZA

Product Code Name

Polymer patient examination glove

Device Record Status

Public Device Record Key

0fe634a7-9bbf-43e4-80ec-26d410250b21

Public Version Date

May 21, 2020

Public Version Number

1

DI Record Publish Date

May 13, 2020

Additional Identifiers

Package DI Number

H65811268592

Quantity per Package

10

Contains DI Package

H65811268591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34