Catalog Number

-

Brand Name

SOL-CARE™ Insulin Syringe w/Fixed Needle

Version/Model Number

100091IM

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

-

Product Code

MEG

Product Code Name

SYRINGE, ANTISTICK

Public Device Record Key

39c4e8f9-1cb5-4ee6-a1d2-d30e5190d70b

Public Version Date

February 18, 2019

Public Version Number

4

DI Record Publish Date

October 23, 2017

Package DI Number

10818392013921

Quantity per Package

100

Contains DI Package

00818392013924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box