Catalog Number

-

Brand Name

PC15 PLASMAKNIFE DISPOSABLE TIP

Version/Model Number

70353115

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

K041285,K041285

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

0ce42d76-98de-4275-afcb-f7c1a8dedf6b

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

May 11, 2017

Package DI Number

00821925026735

Quantity per Package

4

Contains DI Package

00821925040526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-