KATENA PRODUCTS, INC.

Address:123 CLIFF CAVE ROAD,Saint Louis,MO,63129,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 - 00841668100318 Catalog Number : K1-5340

Device Description : ALPHONSO INFANT SPECULUM

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100325 Catalog Number : K1-5350

Device Description : INFANT WIRE SPECULUM 4MM BLADE

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100332 Catalog Number : K1-5355

Device Description : BARRAQUER INFANT WIRE SPECULUM

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100349 Catalog Number : K1-5390

Device Description : FEMTO SPECULUM FLAT WIRE

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100356 Catalog Number : K1-5401

Device Description : COOK EYE SPECULUM #1 SOLID

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100363 Catalog Number : K1-5402

Device Description : COOK EYE SPECULUM #2 SOLID

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100370 Catalog Number : K1-5403

Device Description : COOK EYE SPECULUM #3 SOLID

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100387 Catalog Number : K1-5406

Device Description : MURDOCH EYE SPECULUM #2

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100394 Catalog Number : K1-5407

Device Description : MURDOCH EYE SPECULUM #3

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

Ophthalmic Speculum - 00841668100400 Catalog Number : K1-5411

Device Description : MELLINGER PHACO SPECULUM

Device Class : 1

Duns Number: 085668598

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : Yes

Device Count : 1

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