Catalog Number

-

Brand Name

Insulin Syringe

Version/Model Number

6946

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112057,K112057,K112057

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

7d48f35c-0807-4cde-8698-cc7f3d8d072d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00616784694634

Quantity per Package

5

Contains DI Package

00616784694627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-