Catalog Number

-

Brand Name

GoodSense Comfort Assist Insulin Syringes

Version/Model Number

053108

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 03, 2018

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062702,K062702,K062702

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

af25e2ff-71df-4a52-9f88-7792d51c3262

Public Version Date

July 11, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10370030128737

Quantity per Package

30

Contains DI Package

00370030128730

Package Discontinue Date

July 03, 2018

Package Status

Not in Commercial Distribution

Package Type

Shipper