Catalog Number

7205961

Brand Name

DYONICS / ELECTROBLADE

Version/Model Number

7205961

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"

-

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

K012314,K012314

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

35ef52b1-5bff-4f71-a5fe-4d033264102d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 23, 2015

Package DI Number

23596010466154

Quantity per Package

3

Contains DI Package

03596010466150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX