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

Bayonet Tip - 00810026180002 Catalog Number : SCV-B1

Device Description : Bayonet Tip, 1mm ball, 11cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180019 Catalog Number : SCV-B1/S

Device Description : Bayonet Tip, 1mm ball, 7cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180026 Catalog Number : SCV-B2

Device Description : Bayonet Tip, 2mm ball, 11cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180033 Catalog Number : SCV-B2/S

Device Description : Bayonet Tip, 2mm ball, 7cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180040 Catalog Number : SCV-B3

Device Description : Bayonet Tip, 3mm ball, 11cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180057 Catalog Number : SCV-B3/S

Device Description : Bayonet Tip, 3mm ball, 7cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180064 Catalog Number : SCV-D

Device Description : Bayonet Tip, diamond, 11cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180071 Catalog Number : SCV-D/S

Device Description : Bayonet Tip, diamond, 7cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180088 Catalog Number : SCV-L3

Device Description : Bayonet Tip, 3mm loop, 11cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bayonet Tip - 00810026180095 Catalog Number : SCV-L3/S

Device Description : Bayonet Tip, 3mm loop, 7cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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