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, Polyethylene (GAT) (5) Suture, Nonabsorbable, Synthetic, Polyamide (GAR) (3) Suture, Nonabsorbable, Silk (GAP) (2)

Premarket Exempt

No Yes

Clear

MANI Sutures Polyester - 04546951400736 Catalog Number : 3377

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

MANI Sutures Polyester - 04546951400743 Catalog Number : 3376

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

MANI Sutures Polyester - 04546951400750 Catalog Number : 3375

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

MANI Sutures Polyester - 04546951400767 Catalog Number : 3374

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

MANI Sutures Nylon - 04546951400781 Catalog Number : 3361S

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 - 04546951400798 Catalog Number : 3361

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 - 04546951400828 Catalog Number : 3358S

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 - 04546951400842 Catalog Number : 3356

Device Description : MANI Ophthalmic Sutures

Device Class :

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAP

Prescription Use : Yes

Device Count : 1

MANI Sutures Polyester - 04546951400859 Catalog Number : 3373

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

MANI Sutures Nylon - 04546951400866 Catalog Number : 2856

Device Description : MANI Ophthalmic Sutures

Device Class : 2

Duns Number: 690622428

Premarket Exempt : No

Product Code : GAR

Prescription Use : Yes

Device Count : 1

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