Venus Legacy kit

GUDID 07290016540116

Venus Legacy system and applicators

VENUS CONCEPT LTD

Radio-frequency skin contouring system
Primary Device ID07290016540116
NIH Device Record Keyc3d393d6-99d4-447a-ae03-3fd37398c2b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenus Legacy kit
Version Model NumberPK000002
Company DUNS533127663
Company NameVENUS CONCEPT LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016540116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

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 Date2016-09-24

On-Brand Devices [Venus Legacy kit]

07290016540116Venus Legacy system and applicators
07290016540055Venus Legacy system and applicators

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