Catalog Number

H10012

Brand Name

BOVIE®

Version/Model Number

H10012

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

e42b1eed-a5b7-4a06-b81c-9123588d644c

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

June 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-