Catalog Number

-

Brand Name

SecureSafe Safety Insulin Syringe

Version/Model Number

8904

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"

-

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

K191639,K191639

Product Code

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

b6d72e03-bc4d-470a-95b6-282ae8c858c8

Public Version Date

March 25, 2022

Public Version Number

4

DI Record Publish Date

October 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-