NEW WORLD MEDICAL, INCORPORATED

Address:10763 Edison Court,Rancho Cucamonga,CA,91730,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

IMPLANT, EYE VALVE (KYF) (5) Knife, ophthalmic (HNN) (2) Cannula, ophthalmic (HMX) (1) Forceps, ophthalmic (HNR) (1) Implant, eye valve (KYF) (1) Pump, infusion, ophthalmic (MRH) (1)

Premarket Exempt

No Yes

Clear

Kahook Dual Blade - Glide - 00892064002003 Catalog Number : KDB Glide

Device Description : Kahook Dual Blade Glide

Device Class : 1

Duns Number: 622768711

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Streamline® Surgical System - 00892064002010 Catalog Number : 10-0066

Device Description : Streamline

Device Class : 1

Duns Number: 622768711

Premarket Exempt : No

Product Code : HMX, MRH

Prescription Use : Yes

Device Count : 1

Ahmed™ Glaucoma Valve - 00892064002119 Catalog Number : FP7

Device Description : Silicone Glaucoma Drainage Device

Device Class : 2

Duns Number: 622768711

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

Ahmed™ Glaucoma Valve - 00892064002126 Catalog Number : FP8

Device Description : Pediatric Silicone Glaucoma Drainage Device

Device Class : 2

Duns Number: 622768711

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

Ahmed™ Glaucoma Valve - 00892064002133 Catalog Number : S2

Device Description : Polypropylene Glaucoma Drainage Device

Device Class : 2

Duns Number: 622768711

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

Ahmed™ Glaucoma Valve - 00892064002140 Catalog Number : S3

Device Description : Pediatric Polypropylene Glaucoma Drainage Device

Device Class : 2

Duns Number: 622768711

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

Ahmed™ Glaucoma Valve - 00892064002188 Catalog Number : TE

Device Description : Ahmed Accessory Tube Extender

Device Class : 2

Duns Number: 622768711

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

Ahmed™ Glaucoma Valve - 00892064002270 Catalog Number : M4

Device Description : Porous Polyethylene Glaucoma Drainage Device

Device Class : 2

Duns Number: 622768711

Premarket Exempt : No

Product Code : KYF

Prescription Use : Yes

Device Count : 1

Kahook Dual Blade - 00892064002294 Catalog Number : KDB

Device Description : Kahook Dual Blade

Device Class : 1

Duns Number: 622768711

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ahmed Tube Inserter - 00892064002331 Catalog Number : TI

Device Description : Tube Inserter

Device Class : 1

Duns Number: 622768711

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : Yes

Device Count : 1

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