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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (7) Orthopedic Manual Surgical Instrument (LXH) (3)

Premarket Exempt

No Yes

Clear

Luna 3D - 00813478020308 Catalog Number : LUN3013

Device Description : 13mm Luna 3D Parallel Implant Kit

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020315 Catalog Number : LUN3010-08

Device Description : 10mm, 8-Degree, Luna 3D Lordotic Implant Kit

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020322 Catalog Number : LUN3011-08

Device Description : 11mm, 8-Degree, Luna 3D Lordotic Implant Kit

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020339 Catalog Number : LUN3012-08

Device Description : 12mm, 8-Degree, Luna 3D Lordotic Implant Kit

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020346 Catalog Number : LUN3013-08

Device Description : 13mm, 8-Degree, Luna 3D Lordotic Implant Kit

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020353 Catalog Number : LUN3014-08

Device Description : 14mm, 8-Degree, Luna 3D Lordotic Implant Kit

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020360 Catalog Number : LUN3015-08

Device Description : 15mm, 8-Degree, Luna 3D Lordotic Implant Kit

Device Class : 2

Duns Number: 787732689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020377 Catalog Number : LUN4000

Device Description : Luna 3D Accessory Kit

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020384 Catalog Number : LUN4001

Device Description : Luna 3D Graft Injector Tool, Disposable

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Luna 3D - 00813478020391 Catalog Number : LUN4200

Device Description : Luna 3D Lordotic Accessory Kit

Device Class : 1

Duns Number: 787732689

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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