CERAMISYS LTD

Address:914 Herries Road,Sheffield York,GB

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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

Bone Grafting Material, Synthetic (LYC) (5) Implant, Eye Sphere (HPZ) (5)

Premarket Exempt

No Yes

Clear

Alumina Orbital Implant - 05060171621959 Catalog Number :

Device Description : Porous Alumina Orbital Implant, Sphere, 22mm

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

Orbtex Orbital Implant - 05060171621966 Catalog Number :

Device Description : Porous alumina orbital implant with suture platform, sphere, 16mm

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

Orbtex Orbital Implant - 05060171621973 Catalog Number :

Device Description : Porous alumina orbital implant with suture platform, sphere, 18mm

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

Orbtex Orbital Implant - 05060171621980 Catalog Number :

Device Description : Porous alumina orbital implant with suture platform, sphere, 20mm

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

Orbtex Orbital Implant - 05060171621997 Catalog Number :

Device Description : Porous alumina orbital implant with suture platform, sphere, 22mm

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : HPZ

Prescription Use : Yes

Device Count : 1

ReproBone - 05060171623281 Catalog Number :

Device Description : ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 0.25cc

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

ReproBone - 05060171623298 Catalog Number :

Device Description : ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 0.5cc

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

ReproBone - 05060171623304 Catalog Number :

Device Description : ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 1.0cc

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

ReproBone - 05060171623311 Catalog Number :

Device Description : ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.0cc

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

ReproBone - 05060171623328 Catalog Number :

Device Description : ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.5cc

Device Class : 2

Duns Number: 423459374

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

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