Ulthera System Handpiece

GUDID 00840763100483

ULTHERA, INC.

Ultrasonic body contouring system
Primary Device ID00840763100483
NIH Device Record Key4239226c-4efe-4dd1-bed9-7f37395b8103
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlthera System Handpiece
Version Model NumberUH-2 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
GS100840763100483 [Primary]

FDA Product Code

OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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

On-Brand Devices [Ulthera System Handpiece]

00840763100919UH-2 Rev N
00840763100506UH-2 Rev. J
00840763100490UH-2 Rev. I
00840763100483UH-2 Rev. 1
00840763100438UH-2 Rev. H
00840763100421UH-2 Rev. G
00840763100308UH-2 Rev. F
00840763100292UH-2 Rev. E
00840763100285UH-2 Rev. D
00840763100278UH-2 Rev. C
00840763100261UH-2 Rev. B
00840763100018UH-2 Rev. A
00840763101152UH-2 DS 2.0 Rev A

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