CDC - Premier Value - 31Gx6mm pen needles w/remover - For use with injectors for the subcutaneous - PHARMACY VALUE ALLIANCE, LLC

Duns Number:089138159

Device Description: For use with injectors for the subcutaneous injection of approved drugs, including insulin

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More Product Details

Catalog Number

AN 3890CDC

Brand Name

CDC - Premier Value - 31Gx6mm pen needles w/remover

Version/Model Number

AN 3890CDC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152339,K152339,K152339,K152339

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

8604d638-b9ba-4f2e-9fb6-a5e2a50b3a2f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

00761059891284

Quantity per Package

6

Contains DI Package

00840986023675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve

"PHARMACY VALUE ALLIANCE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 5