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

Microincision Tip - 00810026180354 Catalog Number : STEE305

Device Description : Microincision Tip, 3cm shaft length, 45 degree angle, 1 pc.

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Cable - 00810026180507 Catalog Number : SIEC-JX/B

Device Description : IEC Bipolar Cord, Reusable

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Cable - 00810026180514 Catalog Number : SIEC-BIUC

Device Description : IEC Universal Bipolar Cable, Reusable

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Cable - 00810026180521 Catalog Number : SIEC-BPSCC

Device Description : Bipolar Scissor Cable, Reusable

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Scissor - 00810026180538 Catalog Number : SBPSC08

Device Description : Bipolar Scissor (Crv.) 7" (18cm), Reusable

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Scissor Kit - 00810026180545 Catalog Number : SBPS

Device Description : Bipolar Scissor and Cable Kit

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bi-Turbinate Probe - 00810026180552 Catalog Number : STURB

Device Description : Bi-Turbinate Probe (Bayonet) Reusable 17.5cm

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bi-Turbinate Probe - 00810026180569 Catalog Number : STURB-D

Device Description : Bi-Turbinate Probe (Bayonet) Disposable 17.5cm (1 pc)

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Microincision Tip - 00810026180583 Catalog Number : STEE328

Device Description : Microincision Tip, 2.5cm shaft length, Curved, 1 pc.

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Fingerswitch Wand - 00810026180613 Catalog Number : SIEC-3FHPB/D1

Device Description : Fingerswitch Wand, sterile, single use

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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