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

Specula, ophthalmic (HNC) (10)

Premarket Exempt

No Yes

Clear

Ophthalmic Speculum - 00841668100417 Catalog Number : K1-5500

Device Description : WILLIAMS EYE SPECULUM SMALL

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100424 Catalog Number : K1-5510

Device Description : WILLIAMS EYE SPECULUM LARGE

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100431 Catalog Number : K1-5600

Device Description : LANCASTER EYE SPECULUM SOLID

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100448 Catalog Number : K1-5620

Device Description : LESTER-BURCH EYE SPECULUM

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100455 Catalog Number : K1-5660

Device Description : LIEBERMAN INFANT SPECULUM K-WIRE

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100462 Catalog Number : K1-5665

Device Description : LIEBERMAN INFANT SPECULUM SOLID

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100479 Catalog Number : K1-5668

Device Description : TANNA-LIEBERMAN EYE SPECULUM WITH POSTS

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100486 Catalog Number : K1-5670

Device Description : LIEBERMAN SPECULUM K-WIRE SMALL

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100493 Catalog Number : K1-5671

Device Description : LIEBERMAN SPECULUM K-WIRE

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100509 Catalog Number : K1-5672

Device Description : SELTZER SPECULUM FLAT K-WIRE

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

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