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) (9)

Premarket Exempt

No Yes

Clear

Bipolar Forceps - 00810026180200 Catalog Number : SBF-013D-10

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

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Microincision Tip - 00810026180224 Catalog Number :

Device Description : Microincision Tip, 3cm shaft length, 45 degree angle, 2 pc.

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Blepharoplasty kit - 00810026180248 Catalog Number : SBK-01

Device Description : Blepharoplasty Kit

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Suction Coagulator - 00810026180255 Catalog Number : SSC10

Device Description : Suction coagulator, single use, foot control, 15.24cm WL, 10" diameter, sterile

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Suction Coagulator - 00810026180262 Catalog Number : SSC10B

Device Description : Suction coagulator, single use, hand control, 15.24cm WL, 10" diameter, sterile

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Suction Coagulator - 00810026180279 Catalog Number : SSC12

Device Description : Suction coagulator, single use, foot control, 15.24cm WL, 12" diameter, sterile

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Suction Coagulator - 00810026180286 Catalog Number : SSC12B

Device Description : Suction coagulator, single use, hand control, 15.24cm WL, 12" diameter, sterile

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Suction Coagulator - 00810026180293 Catalog Number : SSC8

Device Description : Suction coagulator, single use, foot control, 15.24cm WL, 8" diameter, sterile

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Suction Coagulator - 00810026180309 Catalog Number : SSC8B

Device Description : Suction coagulator, single use, hand control, 15.24cm WL, 8" diameter, sterile

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Microincision Tip - 00810026180316 Catalog Number : STEE301

Device Description : Microincision Tip, 3cm shaft length, straight, 1 pc.

Device Class :

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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