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

Malleable Tip - 00810026180729 Catalog Number : SFT-L5

Device Description : Malleable Tip, 5mm loop, 18cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180736 Catalog Number : SFT-L5/S

Device Description : Malleable Tip, 5mm loop, 6cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180743 Catalog Number : SFT-L7

Device Description : Malleable Tip, 7mm loop, 18cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180750 Catalog Number : SFT-L7/S

Device Description : Malleable Tip, 7mm loop, 6cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180767 Catalog Number : SFT-N

Device Description : Malleable Tip, Needle, 18cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180774 Catalog Number : SFT-N/S

Device Description : Malleable Tip, Needle, 6cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180781 Catalog Number : SFT-S

Device Description : Malleable Tip, Spatula, 18cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180798 Catalog Number : SFT-S/S

Device Description : Malleable Tip, spatula, 6cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180804 Catalog Number : SFT-W

Device Description : Malleable Tip, fine wire, 18cm shaft length, sterile, single use

Device Class : 2

Duns Number: 117308190

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Malleable Tip - 00810026180811 Catalog Number : SFT-W/S

Device Description : Malleable Tip, fine wire, 6cm 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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