Catalog Number

-

Brand Name

Fortitude

Version/Model Number

SG-0232

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 05, 2022

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KMK

Product Code Name

Device, Intravascular Catheter Securement

Public Device Record Key

d8318331-4676-4888-a826-c737a021527d

Public Version Date

July 06, 2022

Public Version Number

2

DI Record Publish Date

February 10, 2020

Package DI Number

10653599000837

Quantity per Package

30

Contains DI Package

00653599000830

Package Discontinue Date

July 05, 2022

Package Status

Not in Commercial Distribution

Package Type

box