Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

HCT8428CP-2

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

OFF

Product Code Name

Central Venous Catheter Tray

Public Device Record Key

e9b2a0d0-c7b6-489f-93ae-ea6cefed726e

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

November 23, 2020

Package DI Number

M752HCT8428CP25

Quantity per Package

20

Contains DI Package

M752HCT8428CP20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box