Catalog Number

AR1000D-DTS

Brand Name

Qoustic Choice® Wound Therapy System, Disposable Tubing Set

Version/Model Number

AR1000D

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

Yes

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,K062544,K131096,K062544,K131096,K062544,K131096

Product Code

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

022fd308-1e93-4183-9332-89150f4f8dd6

Public Version Date

August 06, 2018

Public Version Number

3

DI Record Publish Date

January 20, 2017

Package DI Number

10853077002203

Quantity per Package

12

Contains DI Package

00853077002206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pallet