Universal Electrosurgical Pad (3M REF 9160) VIVRP02

GUDID 00850794007163

3M Universal Electrosurgical Pad (3m REF #9160), ea

VIVEVE, INC.

Radio-frequency skin contouring system
Primary Device ID00850794007163
NIH Device Record Keyac6c1173-7add-4097-9e55-1df6f8e511b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Electrosurgical Pad (3M REF 9160)
Version Model NumberVIVRP02
Catalog NumberVIVRP02
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850794007163 [Primary]
GS110850794007160 [Package]
Package: Pack [6 Units]
In Commercial Distribution

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 Date2016-10-03

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 Console2018-07-06 Generator

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