Catalog Number

BVX-500BF

Brand Name

J-PLASMA® PRECISE™

Version/Model Number

BVX-500BF

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

K170777,K170777

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

f0d256cb-a907-45d2-a542-e0d5026dd0a4

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

October 03, 2017

Package DI Number

10607151011984

Quantity per Package

1

Contains DI Package

00607151011987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box