Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT20100

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

KPE

Product Code Name

Container, I.V.

Public Device Record Key

9bf80051-9c4c-4672-b337-5d219005b934

Public Version Date

July 10, 2020

Public Version Number

1

DI Record Publish Date

July 02, 2020

Package DI Number

M752HCT201006

Quantity per Package

6

Contains DI Package

M752HCT201002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box