Biogennix, LLC

Address:18009 Sky Park Cir Ste K,Irvine,CA,92614,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

Filler, Bone Void, Calcium Compound (MQV) (8) Instrument, Biopsy (KNW) (3) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (2)

Premarket Exempt

Clear

MAC-Fuse - 00812593020408 Catalog Number : 006-MAC

Device Description : MAC-Fuse, 6cc

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

MAC-Fuse - 00812593020415 Catalog Number : 012-MAC

Device Description : MAC-Fuse, 12cc

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

PRY-Fuse - 00812593020422 Catalog Number : 003-PRY

Device Description : PRY-Fuse, 3cc

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

PRY-Fuse - 00812593020439 Catalog Number : 006-PRY

Device Description : PRY-Fuse, 6cc

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

PRY-Fuse - 00812593020446 Catalog Number : 012-PRY

Device Description : PRY-Fuse, 12cc

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

DirectCell Advanced Bone Grafting System - 00812593020453 Catalog Number : BGS-8C-003-MOR

Device Description : Kit Contains: (1) 003-MOR, 3cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, Ma Kit Contains: (1) 003-MOR, 3cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : KNW, MQV

Prescription Use : Yes

Device Count : 1

DirectCell Advanced Bone Grafting System - 00812593020460 Catalog Number : BGS-8C-006-MOR

Device Description : Kit Contains: (1) 006-MOR, 6cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, Ma Kit Contains: (1) 006-MOR, 6cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV, KNW

Prescription Use : Yes

Device Count : 1

DirectCell Advanced Bone Grafting System - 00812593020477 Catalog Number : BGS-8C-012-MOR

Device Description : Kit Contains: (1) 012-MOR, 12cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, M Kit Contains: (1) 012-MOR, 12cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : KNW, MQV

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020484 Catalog Number : SAS-5025

Device Description : Sypher Bone Screw - 5.0mm Diameter X 25mm Length

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Sypher ALIF Spacer System - 00812593020491 Catalog Number : SAS-5030

Device Description : Sypher Bone Screw - 5.0mm Diameter X 30mm Length

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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