MANI, INC.

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

Suture, Nonabsorbable, Synthetic, Polyamide (GAR) (5) Suture, Nonabsorbable, Silk (GAP) (4) Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (1)

Premarket Exempt

No Yes

Clear

MANI Sutures Nylon - 04546951400484 Catalog Number : 1459S

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

MANI Sutures Nylon - 04546951400507 Catalog Number : 3382

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

MANI Sutures Polyester - 04546951400538 Catalog Number : 4357

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

MANI Sutures Silk - 04546951400545 Catalog Number : 3855S

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAP

Prescription Use : Yes

Device Count : 1

MANI Sutures Silk - 04546951400552 Catalog Number : 3855

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAP

Prescription Use : Yes

Device Count : 1

MANI Sutures Nylon - 04546951400569 Catalog Number : 3854S

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

MANI Sutures Nylon - 04546951400576 Catalog Number : 3854

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

MANI Sutures Nylon - 04546951400583 Catalog Number : 3853S

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

MANI Sutures Silk - 04546951400590 Catalog Number : 4350S

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAP

Prescription Use : Yes

Device Count : 1

MANI Sutures Silk - 04546951400620 Catalog Number : 3851

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAP

Prescription Use : Yes

Device Count : 1

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