Catalog Number

AADR03011204WA0002

Brand Name

Handpiece QS High Power For Harmony XL 1200J (100-120V)

Version/Model Number

1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072564

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

cbd1badb-ebb3-47e5-94aa-e25d72ce3642

Public Version Date

August 10, 2018

Public Version Number

4

DI Record Publish Date

November 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-