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 - 00810026180620 Catalog Number : SFT-B1

Device Description : Malleable Tip, 1mm ball, 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 - 00810026180637 Catalog Number : SFT-B1/S

Device Description : Malleable Tip, 1mm ball, 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 - 00810026180644 Catalog Number : SFT-B2

Device Description : Malleable Tip, 2mm ball, 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 - 00810026180651 Catalog Number : SFT-B2/S

Device Description : Malleable Tip, 2mm ball, 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 - 00810026180668 Catalog Number : SFT-B3

Device Description : Malleable Tip, 3mm ball, 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 - 00810026180675 Catalog Number : SFT-B3/S

Device Description : Malleable Tip, 3mm ball, 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 - 00810026180682 Catalog Number : SFT-D

Device Description : Malleable Tip, diamond, 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 - 00810026180699 Catalog Number : SFT-D/S

Device Description : Malleable Tip, diamond, 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 - 00810026180705 Catalog Number : SFT-L3

Device Description : Malleable Tip, 3mm 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 - 00810026180712 Catalog Number : SFT-L3/S

Device Description : Malleable Tip, 3mm ball, 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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