CONVERTORS - Bilateral Extremity Drape BNS - CARDINAL HEALTH 200, LLC

Duns Number:112164780

Device Description: Bilateral Extremity Drape BNS

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More Product Details

Catalog Number

44209TNSA

Brand Name

CONVERTORS

Version/Model Number

44209TNS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 03, 2023

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

PUI

Product Code Name

Drape, Surgical, Exempt

Device Record Status

Public Device Record Key

bac1c9fd-b0f6-424d-a023-3c9385932a24

Public Version Date

July 21, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2018

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 81
2 A medical device with a moderate to high risk that requires special controls. 111