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

Dual Footswitch - 00810026180828 Catalog Number : SBF-FSCB

Device Description : Dual Bipolar Footswitch (Monopolar Hemo & Bipolar Functions Only)

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Triple Footswitch - 00810026180835 Catalog Number : STF-FSCB

Device Description : Triple Footswitch (Monopolar and Bipolar functions)

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Neutral Plate - 00810026180873 Catalog Number : SIEC-NPD/1

Device Description : Neutral plate (1 pc), disposable, large

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Neutral Plate - 00810026180880 Catalog Number : SIEC-NPD-S1

Device Description : Neutral plate (1 pc), disposable, small

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Assortment Pack - 00810026180897 Catalog Number : SASST-24

Device Description : Assortment Pack (24pcs) Hex Key Adaptor (includes 3 each:Fine Wire (SST-W), Ball Assortment Pack (24pcs) Hex Key Adaptor (includes 3 each:Fine Wire (SST-W), Ball (SST-B3), Spatula (SST-S), Small loop (SST-L5), Large loop (SST-L10), Broad Needle (SBN), Pin (SPIN), Multi-Glide (SVT))

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Reusable Neutral Plate - 00810026180910 Catalog Number : SIEC-NP

Device Description : Reusable Neutral Plate

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Dual Footswitch - 00810026180927 Catalog Number : SDF-FSCB

Device Description : Dual Footswitch (Monopolar Cut/Blend & Bipolar Hemo/Bipolar)

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Neutral Plate - 00810026180934 Catalog Number : SIEC-NPV

Device Description : Neutral plate, Flexible, Reusable, small

Device Class : 2

Duns Number: 117308190

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SP-Tip - 00810026180965 Catalog Number : SASST-27

Device Description : Assortment pack

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SP-Tip - 00810026180996 Catalog Number : SPIN

Device Description : 1/8" Pin Electrode, Hex Key Adaptor (1 pc)

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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