ESTEEM - Nitrile Exam Gloves - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Nitrile Exam Gloves

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More Product Details

Catalog Number

88SNP02S

Brand Name

ESTEEM

Version/Model Number

88SNP02S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

417fccad-4257-40b8-af02-d6b555202c81

Public Version Date

February 05, 2021

Public Version Number

1

DI Record Publish Date

January 28, 2021

Additional Identifiers

Package DI Number

50885380176898

Quantity per Package

4

Contains DI Package

20885380176897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40