Catalog Number

STFI-1435

Brand Name

SOLOPATH

Version/Model Number

STFI-1435

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2019

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"

-

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

36fff2a6-26ad-4416-a6c5-35b0fb3398a1

Public Version Date

March 12, 2020

Public Version Number

3

DI Record Publish Date

May 17, 2018

Package DI Number

50389701012143

Quantity per Package

39

Contains DI Package

00389701012148

Package Discontinue Date

November 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton