Catalog Number

-

Brand Name

Quanta forte

Version/Model Number

PZMS00013

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2018

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

K152714

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

2c2ba629-25a6-49ec-b9fe-4304465b31c7

Public Version Date

July 01, 2019

Public Version Number

5

DI Record Publish Date

August 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-