CARDINAL HEALTH - HEMADUCT, 15FR 3/4 DUCTED W/TROCAR - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: HEMADUCT, 15FR 3/4 DUCTED W/TROCAR

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More Product Details

Catalog Number

JP-HUR151

Brand Name

CARDINAL HEALTH

Version/Model Number

JP-HUR151

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Device Record Status

Public Device Record Key

217e8a2d-89ff-44dd-a008-27b23bac7ed1

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

May 01, 2018

Additional Identifiers

Package DI Number

20885380064118

Quantity per Package

10

Contains DI Package

10885380064111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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