Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

HCT8558PK-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

169f6239-06f2-4e74-8bae-75711c0255de

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 25, 2018

Package DI Number

M752HCT8558PK25

Quantity per Package

10

Contains DI Package

M752HCT8558PK21

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box