Catalog Number

-

Brand Name

Single Use Preloaded Sphincterotome V (Distal Wireguided)

Version/Model Number

KD-VC631Q-07201S

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

5e967055-2fe0-44e7-a6d7-d7b134364678

Public Version Date

May 17, 2022

Public Version Number

5

DI Record Publish Date

September 18, 2018

Package DI Number

14953170399463

Quantity per Package

1

Contains DI Package

04953170399466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-