Catalog Number

-

Brand Name

Sure-Fine Insulin Syringes 0.3CC 29G 12.7mm

Version/Model Number

SM-0001

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

K152879,K152879,K152879,K152879,K152879

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

020264f1-5e2b-4d41-8463-d46db1409dfb

Public Version Date

May 08, 2019

Public Version Number

1

DI Record Publish Date

April 30, 2019

Package DI Number

08800052600041

Quantity per Package

6

Contains DI Package

08800052600034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case