Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT10500

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

66e915fd-0bd0-4e0b-bb1a-705fc26c864a

Public Version Date

July 15, 2020

Public Version Number

1

DI Record Publish Date

July 07, 2020

Package DI Number

M752HCT105006

Quantity per Package

7

Contains DI Package

M752HCT105002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box