SmoothWave RF Generator IEC6-IESU100

GUDID 00810026181108

Soniquence SmoothWave i100 RF Generator

SONIQUENCE, LLC

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system
Primary Device ID00810026181108
NIH Device Record Key4c115a46-b1ff-43c4-8e3a-35d1063d1435
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmoothWave RF Generator
Version Model NumberIEC6-IESU100
Catalog NumberIEC6-IESU100
Company DUNS117308190
Company NameSONIQUENCE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100810026181108 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-15
Device Publish Date2021-04-07

On-Brand Devices [SmoothWave RF Generator]

00810026181115Soniquence SmoothWave i200 RF Generator
00810026181108Soniquence SmoothWave i100 RF Generator

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