CARDINAL HEALTH - GOWN ISO POLYCOATED KNTCUFF UNV YLW - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: GOWN ISO POLYCOATED KNTCUFF UNV YLW

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More Product Details

Catalog Number

7100PG

Brand Name

CARDINAL HEALTH

Version/Model Number

7100PG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 12, 2022

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"

-

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

OEA

Product Code Name

Non-surgical isolation gown

Device Record Status

Public Device Record Key

95fc9555-dcd1-4380-8c7d-ec56457c2f8f

Public Version Date

June 13, 2022

Public Version Number

4

DI Record Publish Date

June 13, 2018

Additional Identifiers

Package DI Number

50885380134249

Quantity per Package

10

Contains DI Package

30885380134245

Package Discontinue Date

June 12, 2022

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