Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

MS-1175

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

aa4ef82e-59a8-43ef-9a59-6a1574572fde

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

June 06, 2018

Package DI Number

M752MS11755

Quantity per Package

24

Contains DI Package

M752MS11751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box