BIOMET

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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

DISPENSER, CEMENT (KIH) (5) TRAY, SURGICAL, INSTRUMENT (FSM) (2)

Premarket Exempt

No Yes

Clear

Optivac Nozzle Revision - 07350023771108 Catalog Number : 4155

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

Cementation Nozzle - 07350023771214 Catalog Number : 4312

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

Angled Nozzle - 07350023771429 Catalog Number : 4149

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

Cement Delivery System - 07350023771719 Catalog Number : 4146

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

Optigun Ratchet - 07350023771788 Catalog Number : 419500

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

TESS BOTTOM INSERT HEMI - 08428898898332 Catalog Number : A1700384

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

TESS TOP INSERT HEMI - 08428898898349 Catalog Number : A1700386

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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