ESCALON MEDICAL CORP.

Address:2440 SOUTH 179TH ST.,NEW BERLIN,WI,53146,US

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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

Light, Surgical, Fiberoptic (FST) (8) Pump, Infusion, Ophthalmic (MRH) (1) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

Fluid/Gas Tubing Set - 00853480006006 Catalog Number : TR9006-11

Device Description : Device is used to maintain intraocular pressure within the posterior chamber dur

Device Class :

Duns Number: 879144426

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Viscous Fluid Pack - 00853480006013 Catalog Number : TR8170-11

Device Description : Single-use procedure pack for injection and aspiration of silicone oil and other

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : MRH

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006020 Catalog Number : TR9800-11

Device Description : Fiber optic light probe for intraocular illumination. Standard light guide, 20

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006037 Catalog Number : TR9800-61

Device Description : Fiber optic light probe for intraocular illumination. Standard light guide, 20

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006044 Catalog Number : TR9801-11

Device Description : Fiber optic light probe for intraocular illumination with tissue manipulation.

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006051 Catalog Number : TR9801-61

Device Description : Fiber optic light probe for intraocular illumination with tissue manipulation.

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006068 Catalog Number : TR9806-11

Device Description : Fiber optic light probe for intraocular illumination with tissue manipulation.

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006075 Catalog Number : TR9806-61

Device Description : Fiber optic light probe for intraocular illumination with tissue manipulation.

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006082 Catalog Number : TR9821-11

Device Description : Wide angle fiber optic light probe for wide view intraocular illumination. Wide

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Fiber Optic Light Guide - 00853480006099 Catalog Number : TR9821-61

Device Description : Wide angle fiber optic light probe for wide view intraocular illumination. Wide

Device Class : 2

Duns Number: 879144426

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

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