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 - 00810026180101 Catalog Number : SCV-L5

Device Description : Bayonet Tip, 5mm 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 - 00810026180118 Catalog Number : SCV-L5/S

Device Description : Bayonet Tip, 5mm 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

Bayonet Tip - 00810026180125 Catalog Number : SCV-L7

Device Description : Bayonet Tip, 7mm 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 - 00810026180132 Catalog Number : SCV-L7/S

Device Description : Bayonet Tip, 7mm 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

Bayonet Tip - 00810026180149 Catalog Number : SCV-N

Device Description : Bayonet Tip, Needle, 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 - 00810026180156 Catalog Number : SCV-N/S

Device Description : Bayonet Tip, Needle, 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 - 00810026180163 Catalog Number : SCV-S

Device Description : Bayonet Tip, Spatula, 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 - 00810026180170 Catalog Number : SCV-S/S

Device Description : Bayonet Tip, Spatula, 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 - 00810026180187 Catalog Number : SCV-W

Device Description : Bayonet Tip, fine wire, 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 - 00810026180194 Catalog Number : SCV-W/S

Device Description : Bayonet Tip, fine wire, 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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