MOLTENO OPHTHALMIC LIMITED

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 Valve (KYF) (9) Implant, Eye Sphere (HPZ) (1)

Premarket Exempt

No

Clear

Molteno - 09419196000014 Catalog Number : D1

Device Description : D1 Pressure Ridge Single Plate Molteno Implant - Sterile

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno - 09419196000021 Catalog Number : DL2

Device Description : DL2 Left Eye, Pressure Ridge, Double Plate Molteno Implant - Sterile

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno - 09419196000038 Catalog Number : DR2

Device Description : DR2 Right Eye, Pressure Ridge, Double Plate Molteno Implant - Sterile

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno - 09419196000052 Catalog Number : L2

Device Description : L2 Left Eye, Double Plate Molteno Implant - Sterile

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno - 09419196000069 Catalog Number : R2

Device Description : R2 Right Eye, Double Plate Molteno Implant - Sterile

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno - 09419196000076 Catalog Number : S1

Device Description : S1 Single Plate Molteno Implant - Sterile

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno - 09419196000083 Catalog Number : P1

Device Description : P1 Paediatric/Microphthalmic 8mm Molteno Implant - Sterile

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno3 - 09419196000090 Catalog Number : GS-175

Device Description : Molteno3 GS (175mm2) Glaucoma Drainage Device

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno3 - 09419196000106 Catalog Number : GL-230

Device Description : Molteno3 GL (230mm2) Glaucoma Drainage Device

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : KYF

Prescription Use : No

Device Count : 1

Molteno M-Sphere - 09419196000168 Catalog Number : MS16

Device Description : MS16 - Molteno M-Sphere® 16mm Natural Hydroxyapatite Orbital Implant

Device Class : 2

Duns Number: 760385075

Premarket Exempt : No

Product Code : HPZ

Prescription Use : No

Device Count : 1

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