Catalog Number

0003

Brand Name

Bovie

Version/Model Number

0003

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

ETN

Product Code Name

Stimulator, Nerve

Public Device Record Key

d3eb372c-44e3-4d53-af05-2f544459b618

Public Version Date

April 25, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

10607151000032

Quantity per Package

10

Contains DI Package

00607151000035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX