Catalog Number

91715

Brand Name

The Cutting Edge System

Version/Model Number

91715

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103840,K103840

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

5bc0c7cd-21c6-4c75-b0da-472b4d13cb31

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2016

Package DI Number

00842102104596

Quantity per Package

10

Contains DI Package

00842102104589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case