Catalog Number

-

Brand Name

Klein

Version/Model Number

3021-03

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

K913514,K913514,K913514

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

a93de59a-82e8-479b-bea6-38b4dcb9d999

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

July 10, 2016

Package DI Number

20841019110021

Quantity per Package

50

Contains DI Package

00841019110027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-