Catalog Number

ESRE

Brand Name

Bovie

Version/Model Number

ESRE

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

K092761,K092761

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f7a0dbe2-a8eb-4c19-9d59-e3e61ad65f63

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

10607151056350

Quantity per Package

50

Contains DI Package

00607151056353

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX