Sure Comfort - 30G x 5/16" (8mm) Single use disposable pen - ALLISON MEDICAL, INC.

Duns Number:825097264

Device Description: 30G x 5/16" (8mm) Single use disposable pen needle for use with most insulin delivery syst 30G x 5/16" (8mm) Single use disposable pen needle for use with most insulin delivery systems (Insulin Pen). Includes 100 sterile needles individually wrapped.

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More Product Details

Catalog Number

24-1115

Brand Name

Sure Comfort

Version/Model Number

24-1115

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152877,K152877,K152877

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

52756167-9788-400e-b024-5251a0e1d86a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 2016

Additional Identifiers

Package DI Number

00786227111599

Quantity per Package

6

Contains DI Package

00786227111575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"ALLISON MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9