Catalog Number

STFI-1435

Brand Name

SOLOPATH

Version/Model Number

STFI-1435

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

3ee74d13-2510-4c15-9b09-35c1c6af1518

Public Version Date

December 13, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50852381004215

Quantity per Package

39

Contains DI Package

00852381004210

Package Discontinue Date

October 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton