Ulthera System Transducer

GUDID 00840763100865

ULTHERA, INC.

Ultrasound hyperthermia system transducer, extracorporeal
Primary Device ID00840763100865
NIH Device Record Keyef8020af-f201-4ed8-a53d-8e452fe14579
Commercial Distribution StatusIn Commercial Distribution
Brand NameUlthera System Transducer
Version Model NumberUT-1 Rev N
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840763100865 [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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-27

On-Brand Devices [Ulthera System Transducer]

00840763100896UT-4N Rev L
00840763100889UT-4 Rev L
00840763100865UT-1 Rev N
00840763100858UT-3 Rev N
00840763100841UT-2 Rev O
00840763100834UT-1N Rev N
00840763100360UT-1N Rev. H
00840763100353UT-3 Rev. H
00840763100346UT-4 Rev. G
00840763100339UT-2 Rev. J
00840763100322UT-4N Rev. G
00840763100315UT-1 Rev H
00840763100070UT-4N Rev. F
00840763100063UT-4 Rev. F
00840763100056UT-3 Rev. G
00840763100049UT-2 Rev. I
00840763100032UT-1N Rev. G

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