Catalog Number

A807

Brand Name

BOVIE

Version/Model Number

A807

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

-

Product Code

HGI

Product Code Name

Electrocautery, Gynecologic (And Accessories)

Public Device Record Key

1e3d852c-1fd6-4798-881d-4844778268aa

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 08, 2016

Package DI Number

10607151018075

Quantity per Package

50

Contains DI Package

00607151018078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX