Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT100GD-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

PEZ

Product Code Name

Central Venous Catheter Dressing Change Kit

Public Device Record Key

26892f54-850b-4093-a261-03d1ba565c2f

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

July 16, 2020

Package DI Number

M752HCT100GD25

Quantity per Package

30

Contains DI Package

M752HCT100GD20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER BOX