MANI, INC.

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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

Knife, ophthalmic (HNN) (6) Cannula, trocar, ophthalmic (NGY) (1)

Premarket Exempt

No Yes

Clear

MANI Infusion Cannula - 14546951405783 Catalog Number :

Device Description : MANI Trocar Kit

Device Class : 1

Duns Number: 690622428

Premarket Exempt : Yes

Product Code : NGY

Prescription Use : No

Device Count : 6

MANI Ophthalmic Knife - 14546951405813 Catalog Number :

Device Description : MANI Ophthalmic Knife

Device Class : 1

Duns Number: 690622428

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 6

MANI Ophthalmic Knife - 14546951405820 Catalog Number :

Device Description : MANI Ophthalmic Knife

Device Class : 1

Duns Number: 690622428

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 6

MANI Ophthalmic Knife - 14546951601550 Catalog Number :

Device Description : MANI Ophthalmic Knife

Device Class : 1

Duns Number: 690622428

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 6

MANI Ophthalmic Knife - 14546951601918 Catalog Number :

Device Description : MANI Ophthalmic Knife

Device Class : 1

Duns Number: 690622428

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 6

MANI Ophthalmic Knife - 14546951604087 Catalog Number :

Device Description : MANI Ophthalmic Knife

Device Class : 1

Duns Number: 690622428

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 6

MANI Ophthalmic Knife - 14546951604858 Catalog Number :

Device Description : MANI Ophthalmic Knife

Device Class : 1

Duns Number: 690622428

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 6

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