Monoject - 12 mL Syringe with Standard Hypodermic Needle - Cardinal Health, Inc.

Duns Number:080935429

Device Description: 12 mL Syringe with Standard Hypodermic Needle

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More Product Details

Catalog Number

1181221112

Brand Name

Monoject

Version/Model Number

1181221112

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2017

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

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

f250de7a-cef1-491a-856e-7b8bd83479f4

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

October 13, 2016

Additional Identifiers

Package DI Number

30884521010783

Quantity per Package

480

Contains DI Package

10884521010789

Package Discontinue Date

April 21, 2017

Package Status

Not in Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17