Ulthera System Control Unit

GUDID 00840763100155

ULTHERA, INC.

Ultrasonic body contouring system
Primary Device ID00840763100155
NIH Device Record Keyd968631e-f3a7-4721-8d4a-5fca55d098a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlthera System Control Unit
Version Model NumberUC-1 Rev. B
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
GS100840763100155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-07

On-Brand Devices [Ulthera System Control Unit]

00840763100902UC-1 Rev R
00840763100254UC-1 Rev. L
00840763100247UC-1 Rev. K
00840763100230UC-1 Rev. J
00840763100223UC-1 Rev. I
00840763100216UC-1 Rev. H
00840763100209UC-1 Rev. G
00840763100193UC-1 Rev. F
00840763100186UC-1 Rev. E
00840763100179UC-1 Rev. D
00840763100162UC-1 Rev. C
00840763100155UC-1 Rev. B
00840763100001UC-1 Rev. A
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