Catalog Number

-

Brand Name

Ulthera System Handpiece

Version/Model Number

UH-2 Rev. B

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

-

Product Code

OHV

Product Code Name

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Public Device Record Key

6cba130c-049a-4490-98a9-be2dea6b4ad8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-