Catalog Number

ES01

Brand Name

Bovie

Version/Model Number

ES01

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

dcdad628-acaf-433f-869e-363f258a32fb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10607151056015

Quantity per Package

50

Contains DI Package

00607151056018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX