PROSIDYAN, INC.

Address:41 Spring Street #107,New Providence,NJ,07974,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) (7) Syringe, Piston (FMF) (2) Dispenser, Cement (KIH) (1)

Premarket Exempt

Clear

FIBERGRAFT BG Putty-GPS - 00856879006106 Catalog Number : 48000040

Device Description : 4 cc spindle drive syringe of BG Putty bioactive bone graft substitute

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

GPS Cannula - 00856879006113 Catalog Number : 61000100

Device Description : 100 mm cannula with pusher

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

GPS Cannula - 00856879006120 Catalog Number : 61000200

Device Description : 200 mm cannula

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

FIBERGRAFT BG Morsels - 00856879006137 Catalog Number : 4600-0300

Device Description : 30cc vial of Fibergraft BG Morsels bioactive bone graft substitute

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

GPS Pusher - 00856879006144 Catalog Number : 6200-0200

Device Description : GPS Pusher

Device Class : 1

Duns Number: 963425488

Premarket Exempt : No

Product Code : KIH

Prescription Use : Yes

Device Count : 1

FIBERGRAFT BG Matrix - 00856879006151 Catalog Number : 55000125

Device Description : BG Matrix Bone Graft Substitute, Large, 12.5 cc

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

FIBERGRAFT BG Matrix - 00856879006212 Catalog Number : 5500-0015

Device Description : BG Matrix Bone Graft Substitute, X-Small, 1.5cc

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

FIBERGRAFT BG Matrix - 00856879006229 Catalog Number : 55000030

Device Description : BG Matrix Bone Graft Substitute, Small, 3cc

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

FIBERGRAFT BG Matrix - 00856879006236 Catalog Number : 55000063

Device Description : BG Matrix Bone Graft Substitute, Medium, 6.25cc.

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

FIBERGRAFT BG Matrix - 00856879006243 Catalog Number : 55000200

Device Description : BG Matrix Bone Graft Substitute, X-Large, 20 cc.

Device Class : 2

Duns Number: 963425488

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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