Catalog Number

0002

Brand Name

BOVIE

Version/Model Number

0002

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

HOY

Product Code Name

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Public Device Record Key

66d2da51-c048-4e02-8a5a-d8cf482dec79

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 10, 2016

Package DI Number

10607151000025

Quantity per Package

10

Contains DI Package

00607151000028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX