LB2 + LF2 kit

GUDID 07290016540062

Venus Legacy LB2 and LF2 applicators package for shipment.

VENUS CONCEPT LTD

Radio-frequency skin contouring system applicator, bipolar
Primary Device ID07290016540062
NIH Device Record Keyad92d90b-c6fb-424b-b1b5-24310a1a16d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLB2 + LF2 kit
Version Model NumberPK000039
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
GS107290016540062 [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

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