Catalog Number

-

Brand Name

Ulthera System Transducer

Version/Model Number

UT-3 Rev. H

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K134032

Product Code

OHV

Product Code Name

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Public Device Record Key

c7fdd207-6567-4cb1-abb5-0e83d38c0a1b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-