BOSTON SCIENTIFIC CORPORATION

Address:100 BOSTON SCIENTIFIC WAY,Marlborough,MA,01752,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

Endoscopic video imaging system/component, gastroenterology-urology (FET) (4) ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE (MNL) (3) Endoscope channel accessory (ODC) (1) Submucosal injection agent (PLL) (1) Unit, electrosurgical, endoscopic (with or without accessories) (KNS) (1)

Premarket Exempt

No Yes

Clear

Compliance EndoKit™ - 08714729991892 Catalog Number : CEK-2030

Device Description : Compliance EndoKit

Device Class : 1

Duns Number: 021717889

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

Compliance EndoKit™ - 08714729991915 Catalog Number : CEK-2031

Device Description : Compliance EndoKit

Device Class : 1

Duns Number: 021717889

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

Compliance EndoKit™ - 08714729991939 Catalog Number : CEK-2032

Device Description : Compliance EndoKit

Device Class : 1

Duns Number: 021717889

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : Yes

Device Count : 1

rezum - 08714729992547 Catalog Number : M006D2201-003

Device Description : Delivery Device Kit for BPH

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

EXALT™ - 08714729993612 Catalog Number :

Device Description : Controller

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

EXALT™ - 08714729993636 Catalog Number :

Device Description : Controller

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

EXALT™ - 08714729993643 Catalog Number :

Device Description : Controller

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

EXALT™ - 08714729993667 Catalog Number :

Device Description : Controller

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

Orca® - 08714729993728 Catalog Number : SUV-618-01

Device Description : Single Use Air/Water and Suction Valves

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

ORISE™ Gel - 08714729993834 Catalog Number : M00519220

Device Description : Submucosal Lifting Agent

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 1

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