Catalog Number

5311J

Brand Name

Securegard

Version/Model Number

1.0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K993609,K993609,K993609

Product Code

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

677a7c10-0ee1-45b2-b269-93b5c006cfa3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

5999039500085

Quantity per Package

10

Contains DI Package

5999039500078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton