FINCERAMICA FAENZA SPA

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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, Nonalterable Compound For Cranioplasty (PJN) (1) Plate, Cranioplasty, Preformed, Non-Alterable (GXN) (1)

Premarket Exempt

Clear

NA - 18054188160611 Catalog Number : PFS900000-00-00

Device Description : Patient specific cranial/craniofacial implant in hydroxyapatite ( US commercial Patient specific cranial/craniofacial implant in hydroxyapatite ( US commercial name CustomizedBone Service)

Device Class : 2

Duns Number: 442706875

Premarket Exempt : No

Product Code : PJN, GXN

Prescription Use : Yes

Device Count : 1

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