Catalog Number

AR1000-H/P

Brand Name

Qoustic Wound Therapy System® Converter Hand Piece

Version/Model Number

AR1000

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"

Yes

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

K062544,K131096

Product Code

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

d310e6c0-f795-40e8-a3a0-970d36ee9cd1

Public Version Date

August 06, 2018

Public Version Number

3

DI Record Publish Date

March 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-