Catalog Number

PR10FDP350

Brand Name

Bipolar Coagulation Probe

Version/Model Number

00884450121238

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KNS

Product Code Name

Unit, electrosurgical, endoscopic (with or without accessories)

Public Device Record Key

15e7b515-4661-48e3-9db4-dd9a273fa090

Public Version Date

May 19, 2021

Public Version Number

5

DI Record Publish Date

September 28, 2016

Package DI Number

10884450121235

Quantity per Package

5

Contains DI Package

00884450121238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-