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

Cement, Bone, Vertebroplasty (NDN) (2) Injector, Vertebroplasty (Does Not Contain Cement) (OAR) (1) Needle, Aspiration And Injection, Disposable (GAA) (1)

Premarket Exempt

No Yes

Clear

Kiva - 00813478020407 Catalog Number : ACC5350

Device Description : Kiva UltraFlex Cement Needle Kit

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020414 Catalog Number : MS3643

Device Description : Mixing and Injection System

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

Blazer - 00813478020421 Catalog Number : MS2079

Device Description : F20 Radiopaque Bone Cement

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020438 Catalog Number : MS3101

Device Description : Verterbral Augmentation Cement

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

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