BENVENUE MEDICAL, INC.

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

Bone Cement (LOD) (6) Cement, Bone, Vertebroplasty (NDN) (6) Needle, Aspiration And Injection, Disposable (GAA) (2) Spinal Channeling Instrument, Vertebroplasty (OCJ) (2)

Premarket Exempt

No Yes

Clear

Kiva - 00813478020001 Catalog Number : KIV2100

Device Description : Kiva VCF Treatment System, Fisrt Fracture Kit, Right

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020018 Catalog Number : KIV2150

Device Description : Kiva VCF Treatment System, Additional Fracture Kit, Right

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020025 Catalog Number : KIV2200

Device Description : Kiva VCF Treatment System, First Fracture Kit, Left

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020032 Catalog Number : KIV2250

Device Description : Kiva VCF Treatment System, Additional Fracture Kit, Left

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020049 Catalog Number : FRS2100

Device Description : Kiva VCF Treatment System, First Fracture, Right

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020056 Catalog Number : FRS2200

Device Description : Kiva VCF Treatment System, First Fracture, Left

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020063 Catalog Number : PLT1900

Device Description : Kiva Pilot, Right

Device Class : 1

Duns Number: 787732689

Premarket Exempt : No

Product Code : OCJ

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020070 Catalog Number : PLT1910

Device Description : Kiva Pilot, Left

Device Class : 1

Duns Number: 787732689

Premarket Exempt : No

Product Code : OCJ

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020087 Catalog Number : ACC1510

Device Description : CorePlus Bone Biopsy Needle, 15GA

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Kiva - 00813478020094 Catalog Number : ACC1520

Device Description : CorePlus Bone Biopsy Needle, 11GA

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

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