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) (10)

Premarket Exempt

Clear

osteoSPAN - 00812593020606 Catalog Number : 100-SLF

Device Description : 6x6x40mm osteoSPAN Blocks

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

osteoSPAN - 00812593020613 Catalog Number : 190-SLF

Device Description : 9x6x40mm osteoSPAN Blocks

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

osteoSPAN - 00812593020620 Catalog Number : 100-30G

Device Description : 1-4mm osteoSPAN Granules

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Morpheus - 00812593020637 Catalog Number : 003-MOR

Device Description : 3cc Morpheus

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Morpheus - 00812593020644 Catalog Number : 006-MOR

Device Description : 6cc Morpheus

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Morpheus - 00812593020651 Catalog Number : 012-MOR

Device Description : 12cc Morpheus

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Morpheus - 00812593020668 Catalog Number : 009-MOR

Device Description : 9cc Morpheus

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Agilon - 00812593020675 Catalog Number : Agilon

Device Description : Agilon Moldable 1.5cc

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Agilon - 00812593020682 Catalog Number : 003-AGL

Device Description : 3cc Agilon Moldable

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Agilon - 00812593020699 Catalog Number : 006-AGL

Device Description : 6cc Agilon Moldable

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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