Catalog Number

-

Brand Name

Single Use Preloaded Sphincterotome V

Version/Model Number

KD-V611M-07301S

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"

Yes

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

KNS

Product Code Name

Unit, electrosurgical, endoscopic (with or without accessories)

Public Device Record Key

aecd4898-00a5-47ed-8434-8574da05539b

Public Version Date

May 24, 2022

Public Version Number

5

DI Record Publish Date

January 05, 2018

Package DI Number

14953170403122

Quantity per Package

1

Contains DI Package

04953170403125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-