Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

682-5MLSYRG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

eec79cf6-2890-4c63-8604-737823f085d6

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

December 19, 2017

Package DI Number

M7526825MLSYRG5

Quantity per Package

5

Contains DI Package

M7526825MLSYRG1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box