CARDINAL HEALTH - SYRINGE 3CC LUER SLIP - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: SYRINGE 3CC LUER SLIP

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More Product Details

Catalog Number

SY35003LS

Brand Name

CARDINAL HEALTH

Version/Model Number

SY35003LS

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

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

9c495ebc-cd18-4027-8d16-0902a3a69569

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 08, 2016

Additional Identifiers

Package DI Number

20885380119566

Quantity per Package

100

Contains DI Package

10885380119569

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