Ulthera System

GUDID 00840763100476

ULTHERA, INC.

Ultrasonic body contouring system
Primary Device ID00840763100476
NIH Device Record Key53bac124-1176-43c9-81e9-849fb2410fc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlthera System
Version Model NumberUC-1 Rev 1
Company DUNS010981554
Company NameULTHERA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840763100476 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-05-23

Devices Manufactured by ULTHERA, INC.

00840763101169 - Ulthera System Cart2024-05-29
10840763100107 - Cellfina System Procedure Kit (Single Package)2024-05-09
00840763101145 - Ulthera System Control Unit PRIME2024-04-18
00840763101152 - Ulthera System Handpiece2024-04-16
00840763100742 - Cellfina Motor Module Device and Package2020-02-03
00840763100025 - Ulthera System Transducer DS 7-3.0 2019-07-26
00840763100414 - Cellfina System Disposable Tray2019-07-26
00840763100520 - Cellfina System Disposable Tray2019-07-26

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