SONIQUENCE, LLC

Address:2477 Grand Avenue,Baldwin,NY,11510,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (10)

Premarket Exempt

No Yes

Clear

SmoothWave RF Generator - 00810026181108 Catalog Number : IEC6-IESU100

Device Description : Soniquence SmoothWave i100 RF Generator

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SmoothWave RF Generator - 00810026181115 Catalog Number : IEC6-IESU200

Device Description : Soniquence SmoothWave i200 RF Generator

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SP-Tip - 00810026181139 Catalog Number : SVT

Device Description : Multi-Glide Tip Electrode, Hex Key Adaptor (1 pc)

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SP-Tip - 00810026181146 Catalog Number : SST-SW2

Device Description : LLETZ Electrode With Hex Key

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Forceps - 00810026181160 Catalog Number : SBF-004D-10

Device Description : Bipolar Forceps sterile, Straight, 7 3/4", 1.0mm tip

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Forceps - 00810026181184 Catalog Number : SBF-001D-05

Device Description : Bipolar Forceps sterile, Jeweler #5, 4 1/2", 0.5mm tip

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Neutral Plate - 00810026181191 Catalog Number : SIEC-NPRV

Device Description : Neutral plate, Rigid, Reusable, small

Device Class : 2

Duns Number: 117308190

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Wand - 00810026181207 Catalog Number : SDTF-13

Device Description : Bipolar Wand, Sterile, Disposable, 13cm WL, 2.5mm Diameter

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Wand - 00810026181214 Catalog Number : SDTF-18

Device Description : Bipolar Wand, Sterile, Disposable, 18cm WL, 2.5mm Diameter

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Wand - 00810026181221 Catalog Number : SDTF-24

Device Description : Bipolar Wand, Sterile, Disposable, 24cm WL, 2.5mm Diameter

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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