Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT3916

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

3bac9842-bbfa-4e56-a470-58b7abcd1225

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Package DI Number

M752HCT39162

Quantity per Package

4

Contains DI Package

M752HCT39161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner bag