Catalog Number

-

Brand Name

Pathfinder

Version/Model Number

M00551590

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

OCY

Product Code Name

Endoscopic guidewire, gastroenterology-urology

Public Device Record Key

bc5e277e-d2df-4eec-ba76-4cc6b97239d9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

08714729156116

Quantity per Package

2

Contains DI Package

08714729746782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-