CONVERTORS - Surgical Mask W/Anti Fog Foam Strip and - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Surgical Mask W/Anti Fog Foam Strip and Wraparound Eye Shield

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More Product Details

Catalog Number

AT74635

Brand Name

CONVERTORS

Version/Model Number

AT74635

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

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

FXX

Product Code Name

Mask, surgical

Device Record Status

Public Device Record Key

52490994-6a5e-48ac-9114-4f46219f1a00

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

July 26, 2016

Additional Identifiers

Package DI Number

50885380072145

Quantity per Package

4

Contains DI Package

20885380072144

Package Discontinue Date

January 01, 2025

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