Catalog Number

BVX-450N

Brand Name

J-PLASMA® PRECISE™

Version/Model Number

BVX-450N

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

K151325,K151325

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

35aab0ef-51f0-4b9e-8ed3-99fc1a461dcb

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10607151010192

Quantity per Package

1

Contains DI Package

00607151010195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX