CONVERTORS - Neuro Drape BNS - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Neuro Drape BNS

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More Product Details

Catalog Number

41051NS

Brand Name

CONVERTORS

Version/Model Number

41051NS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 16, 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"

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

ERY

Product Code Name

Drape, surgical, ent

Device Record Status

Public Device Record Key

cf57f779-663c-4a92-9363-af5688f9f053

Public Version Date

July 18, 2022

Public Version Number

6

DI Record Publish Date

June 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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