BENVENUE MEDICAL, INC.

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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

Stylet, Surgical, General & Plastic Surgery (GAH) (3) Bit, Drill (HTW) (2) Spinal Channeling Instrument, Vertebroplasty (OCJ) (2) Needle, Aspiration And Injection, Disposable (GAA) (1) Injector, Vertebroplasty (Does Not Contain Cement) (OAR) (1) Cannula, Surgical, General & Plastic Surgery (GEA) (1) Cement, Bone, Vertebroplasty (NDN) (1)

Premarket Exempt

No Yes

Clear

Kiva - 00813478020100 Catalog Number : ACC5220

Device Description : Bone Drill, 7GA x 19cm

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020117 Catalog Number : ACC5225

Device Description : Bone Drill, 7GA x 17cm

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020124 Catalog Number : ACC5230

Device Description : Kiva Diamond Tip Access Needle, 11GA

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GAH

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020131 Catalog Number : ACC5240

Device Description : Kiva Bevel Tip Access Needle, 11GA

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GAH

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020148 Catalog Number : ACC5250

Device Description : Kiva Cement Needle Set

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020155 Catalog Number : ACC5260

Device Description : Kiva Trocar Tip Access Needle, 11GA

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GAH

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020162 Catalog Number : ACC5270

Device Description : Kiva Introducer Set

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020179 Catalog Number : VAK1800

Device Description : Vertebral Augmentation Cement Kit for Use with Kiva

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : NDN, OAR

Prescription Use : Yes

Device Count : 1

Blazer - 00813478020186 Catalog Number : BCN3120

Device Description : Blazer-C Vertebral Augmentation System

Device Class : 1

Duns Number: 787732689

Premarket Exempt : No

Product Code : OCJ

Prescription Use : Yes

Device Count : 1

Blazer - 00813478020193 Catalog Number : BZK3130

Device Description : Blazer-C Vertebral Augmentation Kit

Device Class : 1

Duns Number: 787732689

Premarket Exempt : No

Product Code : OCJ

Prescription Use : Yes

Device Count : 1

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