Catalog Number

-

Brand Name

UNIVERSAL PLASMACISION (UPC) REUSABLE HANDPIECE

Version/Model Number

70353008

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2017

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

-

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

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

e18097f3-68c9-4d97-891e-937fab9cf935

Public Version Date

October 06, 2022

Public Version Number

4

DI Record Publish Date

May 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-