Ultra-Care Pen Needles 31G 3/16" 100 Ct - Insulin Pen Needle - ARISE MEDICAL LLC

Duns Number:081149273

Device Description: Insulin Pen Needle

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More Product Details

Catalog Number

-

Brand Name

Ultra-Care Pen Needles 31G 3/16" 100 Ct

Version/Model Number

240394

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)

-

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

c80bbf14-120a-45d3-84aa-a7a09e7705c6

Public Version Date

January 20, 2020

Public Version Number

2

DI Record Publish Date

November 29, 2018

Additional Identifiers

Package DI Number

00372217006275

Quantity per Package

12

Contains DI Package

00372217006022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ARISE MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 17