VIVEVE Console VIVGE01

GUDID 00850794007118

Generator

VIVEVE, INC.

Radio-frequency skin contouring system
Primary Device ID00850794007118
NIH Device Record Keye369b5fc-3544-46c8-bf6e-4d752749744e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIVEVE Console
Version Model NumberVIVGE01
Catalog NumberVIVGE01
Company DUNS025398094
Company NameVIVEVE, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850794007118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

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 Date2016-09-23

Devices Manufactured by VIVEVE, INC.

10850794007009 - 5 cm Treatment Tip2018-07-06 Viveve Treatment Tip, 5CM, Single
10850794007016 - 5 cm Treatment Tip S2018-07-06 Viveve Treatment Tip, 5 cm, Secure, Single
10850794007023 - 8 cm Treatment Tip2018-07-06 Viveve Treatment Tip, 8CM, Single
10850794007054 - CRYOGEN CANISTER2018-07-06 Cryogen Canister, R134a, can, ea
10850794007078 - COUPLING FLUID2018-07-06 Viveve Coupling Fluid, 30ml bottle, each
00850794007088 - VIVEVE Hand Piece2018-07-06 Hand Piece
00850794007101 - VIVEVE Hand Piece S2018-07-06 handpiece, Secure
00850794007118 - VIVEVE Console2018-07-06Generator
00850794007118 - VIVEVE Console2018-07-06 Generator

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