Catalog Number

GI 085140-2

Brand Name

Pathfinder

Version/Model Number

GI 085140-2

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

K191415

Product Code

FED

Product Code Name

Endoscopic Access Overtube, Gastroenterology-Urology

Public Device Record Key

3129373f-0e27-4c18-a96a-e6fe974f2c5c

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

January 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-