Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT4332

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

2a2d74d7-3fde-4dbc-b1a6-a3e9c5919c20

Public Version Date

July 21, 2020

Public Version Number

1

DI Record Publish Date

July 13, 2020

Package DI Number

M752HCT43325

Quantity per Package

6

Contains DI Package

M752HCT43321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box