Catalog Number

-

Brand Name

SOL-M Insulin Syringe

Version/Model Number

1612812B

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

158b5740-e76b-453c-8dd0-8021c9e0d75a

Public Version Date

July 11, 2019

Public Version Number

1

DI Record Publish Date

July 03, 2019

Package DI Number

20818392019814

Quantity per Package

10

Contains DI Package

10818392019817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case