Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

HCT8428CP-1

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"

-

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

80d2a503-fafe-4994-a690-ba6bbbe4a6b0

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

January 05, 2018

Package DI Number

M752HCT8428CP15

Quantity per Package

20

Contains DI Package

M752HCT8428CP11

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box