Catalog Number

-

Brand Name

Single Use Electrosurgical Knife KD-655

Version/Model Number

KD-655U

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

K171158,K171158

Product Code

KNS

Product Code Name

Unit, electrosurgical, endoscopic (with or without accessories)

Public Device Record Key

d441c360-e079-48ab-b1a7-69d2e534bde3

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

December 19, 2017

Package DI Number

14953170405645

Quantity per Package

1

Contains DI Package

04953170405648

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-