IANTECH, INC.

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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

Unit, Phacofragmentation (HQC) (2) Hook, Ophthalmic (HNQ) (1)

Premarket Exempt

No Yes

Clear

miLOOP - 00860000122306 Catalog Number :

Device Description : Ophthalmic Instrument. Lens Fragmentation Device.

Device Class :

Duns Number: 080125056

Premarket Exempt : Yes

Product Code : HNQ

Prescription Use : Yes

Device Count : 5

MICOR extractor - 00860000122368 Catalog Number :

Device Description : Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.

Device Class :

Duns Number: 080125056

Premarket Exempt : No

Product Code : HQC

Prescription Use : Yes

Device Count : 5

MICOR drive - 00860000122375 Catalog Number :

Device Description : Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR e Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector

Device Class : 2

Duns Number: 080125056

Premarket Exempt : No

Product Code : HQC

Prescription Use : Yes

Device Count : 1

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