Catalog Number

FD-SSFX01-25-01

Brand Name

Suresafe 1ml Syringe

Version/Model Number

1ml Syringe - 25G x 1"

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

K141349,K141349,K141349

Product Code

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

51f7723e-c30f-4571-b2cc-cbab1651d8f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 11, 2016

Package DI Number

05391530750325

Quantity per Package

21

Contains DI Package

05391530750318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-