Catalog Number

-

Brand Name

Precision Bipolar

Version/Model Number

PBD02

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

K102983,K102983

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

a42eb4c8-5c4f-4124-9de1-9dda66ae372b

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

June 15, 2016

Package DI Number

10803622132459

Quantity per Package

6

Contains DI Package

00803622132452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE