KATENA PRODUCTS, INC.

Address:6 CAMPUS DRIVE,Parsippany,NJ,07054,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

Forceps, ophthalmic (HNR) (4) Spatula, ophthalmic (HND) (4) Knife, ophthalmic (HNN) (2)

Premarket Exempt

No Yes

Clear

Oph.Spatula - 00852979003540 Catalog Number : 05-4035L

Device Description : Nagahara Chopper, LH Dom., Titanium

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HND

Prescription Use : Yes

Device Count : 1

Oph.Spatula - 00852979003557 Catalog Number : 05-4059

Device Description : Chu ICL Manipulator, Titanium

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HND

Prescription Use : Yes

Device Count : 1

Oph.Spatula - 00852979003564 Catalog Number : 05-4060

Device Description : Batlle ICL Manipulator

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HND

Prescription Use : Yes

Device Count : 1

Oph.Knife - 00852979003625 Catalog Number : 05-5050

Device Description : Diamond Knife, Angled, 3.0mm Blade

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Oph.Knife - 00852979003632 Catalog Number : 05-5086

Device Description : Diamond Knife, 3-D Ang. Trap. 2.5-3.5mm

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Oph.Spatula - 00852979003649 Catalog Number : 05-4040L

Device Description : Seibel Chopper, Angled, LH Dominant, Titanium

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HND

Prescription Use : Yes

Device Count : 1

Oph.Forceps - 00852979003656 Catalog Number : 05-2329

Device Description : Brown-Grabow Caps. Cyst. Fcps, Titanium

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : Yes

Device Count : 1

Oph.Forceps - 00852979003670 Catalog Number : 05-2211

Device Description : Pierse Corneal Fcps, Straight, Titanium

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : Yes

Device Count : 1

Oph.Forceps - 00852979003694 Catalog Number : 05-2131

Device Description : Tying Fcps Round Hdl, Curved, Titanium

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : Yes

Device Count : 1

Oph.Forceps - 00852979003861 Catalog Number : 05-2220

Device Description : Castroviejo Fcps, Str, .12mm, Titanium

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : Yes

Device Count : 1

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