Catalog Number

-

Brand Name

Quantaforte

Version/Model Number

OAM001904

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

9ce9fd13-6035-46e6-87b5-6be69be34d63

Public Version Date

July 01, 2019

Public Version Number

5

DI Record Publish Date

August 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-