PROTEXIS - Sterile Latex Powder-Free Surgical Gloveswith - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Sterile Latex Powder-Free Surgical Gloveswith Nitrile Coating

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More Product Details

Catalog Number

2D72NS75X

Brand Name

PROTEXIS

Version/Model Number

2D72NS75X

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KGO

Product Code Name

Surgeon's gloves

Device Record Status

Public Device Record Key

def03878-effd-4d32-a5b9-e95b828f2138

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

April 05, 2018

Additional Identifiers

Package DI Number

50885380032033

Quantity per Package

4

Contains DI Package

20885380032032

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