Catalog Number

-

Brand Name

SOL-GUARD™ Insulin Safety Syringe with Fixed Needle

Version/Model Number

200092SG

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

05a8d2d6-316d-499c-8015-bc3dc13b0b70

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 23, 2017

Package DI Number

20818392013683

Quantity per Package

8

Contains DI Package

10818392013686

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case