Catalog Number

-

Brand Name

ELECTROSURGICAL KNIFE

Version/Model Number

KD-1L-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2022

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

-

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

K062517,K062517

Product Code

KGE

Product Code Name

FORCEPS, BIOPSY, ELECTRIC

Public Device Record Key

0eff96c6-15d6-4a0c-907f-83134b69eabd

Public Version Date

August 11, 2022

Public Version Number

4

DI Record Publish Date

July 02, 2018

Package DI Number

14953170037709

Quantity per Package

1

Contains DI Package

04953170037702

Package Discontinue Date

August 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-