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) (8) Suture, Nonabsorbable, Silk (GAP) (2)

Premarket Exempt

No Yes

Clear

MANI Sutures Nylon - 04546951401269 Catalog Number : 1401S

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 - 04546951401283 Catalog Number : 1410S

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 - 04546951401290 Catalog Number : 1410

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 - 04546951401306 Catalog Number : 1407S

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 - 04546951401313 Catalog Number : 1407

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 - 04546951401320 Catalog Number : 1406S

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 - 04546951401344 Catalog Number : 1406

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 - 04546951401351 Catalog Number : 1405

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 - 04546951401405 Catalog Number : 1413S

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 - 04546951401412 Catalog Number : 1413

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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