Catalog Number

STFI-1635

Brand Name

SOLOPATH

Version/Model Number

STFI-1635

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 30, 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

7b2a0b04-8fb9-46c2-b653-c8140120c195

Public Version Date

December 13, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50852381004239

Quantity per Package

39

Contains DI Package

00852381004234

Package Discontinue Date

October 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton