Catalog Number

AR01

Brand Name

Bovie

Version/Model Number

AR01

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

5427c832-2fb4-4a5b-accb-d9d01d53f877

Public Version Date

November 01, 2021

Public Version Number

5

DI Record Publish Date

September 26, 2016

Package DI Number

10607151003149

Quantity per Package

5

Contains DI Package

00607151003142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX