CARDINAL HEALTH - STERILE 1X6 TEFLON FELT KIT - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: STERILE 1X6 TEFLON FELT KIT

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More Product Details

Catalog Number

SID23TFCSB

Brand Name

CARDINAL HEALTH

Version/Model Number

SID23TFCSB

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"

Yes

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

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Record Status

Public Device Record Key

74f790e6-0ba7-4fb5-9bfe-06138c4f5e76

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

September 18, 2015

Additional Identifiers

Package DI Number

50885425282706

Quantity per Package

50

Contains DI Package

00885425282701

Package Discontinue Date

-

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