FLEXAL - Nitrile Exam Gloves Flexal w Dispensing Film - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Nitrile Exam Gloves Flexal w Dispensing Film

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More Product Details

Catalog Number

88TNF02S

Brand Name

FLEXAL

Version/Model Number

88TNF02S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

57fd75e0-16d5-492a-a8ae-b40a7195eba5

Public Version Date

December 31, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2018

Additional Identifiers

Package DI Number

50885380140851

Quantity per Package

10

Contains DI Package

20885380140850

Package Discontinue Date

December 31, 2021

Package Status

Not 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