Catalog Number

26016

Brand Name

EXEL Comfort Point Insulin Syringe

Version/Model Number

26016

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K861153,K861153,K861153

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

1c2eecba-56f4-4429-b58f-23ff71c065b4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

30020221260169

Quantity per Package

5

Contains DI Package

20020221260162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-