MOLTENO OPHTHALMIC LIMITED

Address:152 FREDERICK ST.,DUNEDIN Otago,NZ

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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

Implant, Eye Sphere (HPZ) (4) Implant, Eye Valve (KYF) (2)

Premarket Exempt

Clear

Molteno M-Sphere - 09419196000175 Catalog Number : MS18

Device Description : MS18 - Molteno M-Sphere® 18mm Natural Hydroxyapatite Orbital Implant

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : HPZ

Prescription Use : No

Device Count : 1

Molteno M-Sphere - 09419196000182 Catalog Number : MS20

Device Description : MS20 - Molteno M-Sphere® 20mm Natural Hydroxyapatite Orbital Implant

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : HPZ

Prescription Use : No

Device Count : 1

Molteno M-Sphere - 09419196000199 Catalog Number : MS22

Device Description : MS22 - Molteno M-Sphere® 22mm Natural Hydroxyapatite Orbital Implant

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : HPZ

Prescription Use : No

Device Count : 1

Molteno MoaBone - 09419196000205 Catalog Number : MS08

Device Description : MS08 - MoaBone® Reconstruction pack (4 assorted segments)

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : HPZ

Prescription Use : No

Device Count : 1

Molteno3 - 09419196000212 Catalog Number : SS-185

Device Description : Molteno3 SS (185mm2) Glaucoma Drainage Device

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno3 - 09419196000229 Catalog Number : SL-245

Device Description : Molteno3 SL (245mm2) Glaucoma Drainage Device

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

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