Catalog Number

-

Brand Name

Single Use Electrosurgical Knife KD-625

Version/Model Number

KD-625LR

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

K182408,K182408

Product Code

KNS

Product Code Name

Unit, electrosurgical, endoscopic (with or without accessories)

Public Device Record Key

3bf1bb20-3607-44a6-a684-499c9446185f

Public Version Date

December 17, 2021

Public Version Number

2

DI Record Publish Date

May 21, 2019

Package DI Number

14953170407823

Quantity per Package

1

Contains DI Package

04953170407826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-