Monoject - Standard Hypodermic Needle,Polypropylene Hub - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Standard Hypodermic Needle,Polypropylene Hub

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More Product Details

Catalog Number

1188821112

Brand Name

Monoject

Version/Model Number

1188821112

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

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

f28e5ff1-83d9-412b-bf86-4fceeaaad117

Public Version Date

October 23, 2019

Public Version Number

9

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

30884521007165

Quantity per Package

100

Contains DI Package

10884521007215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK

"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