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) (4) Instrument, Biopsy (KNW) (4)

Premarket Exempt

Clear

Agilon - 00812593020705 Catalog Number : 012-AGL

Device Description : 12cc Agilon Moldable

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

DirectCell Advanced Bone Grafting System - 00812593021542 Catalog Number : BGS-8C-010-AGS

Device Description : Kit Contains: (1) 010-AGS, Medium Agilon Strip Bone Grafting Product, (1) MC-RAN Kit Contains: (1) 010-AGS, Medium Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellution 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 - 00812593021559 Catalog Number : BGS-8C-020-AGS

Device Description : Kit Contains: (1) 020-AGS, Large Agilon Strip Bone Grafting Product, (1) MC-RAN- Kit Contains: (1) 020-AGS, Large Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : KNW, MQV

Prescription Use : Yes

Device Count : 1

DirectCell Autograft and Marrow Harvesting System - 00812593021566 Catalog Number : AMS-MC-RAN-8C

Device Description : Contains: (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit

Device Class : 2

Duns Number: 832270370

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

DirectCell Advanced Bone Grafting System - 00812593021573 Catalog Number : BGS-8C-001-AGL

Device Description : Kit Contains: (1) 001-AGL, 1.5cc Agilon Moldable Bone Grafting Product, (1) MC-R Kit Contains: (1) 001-AGL, 1.5cc Agilon Moldable 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

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