Catalog Number

SR-2025

Brand Name

SOLOPATH

Version/Model Number

SR-2025

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

b6a8bcf2-ae1e-4ab6-801c-71165d8cc1d2

Public Version Date

December 13, 2019

Public Version Number

4

DI Record Publish Date

March 13, 2017

Package DI Number

50852381011893

Quantity per Package

39

Contains DI Package

00852381011898

Package Discontinue Date

October 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton