OMNIA MEDICAL, LLC

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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

Orthopedic Manual Surgical Instrument (LXH) (6) Awl (HWJ) (1) Probe (HXB) (1) Tray, Surgical (LRP) (1) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

No Yes

Clear

Omnia Medical VBR - 00843511121259 Catalog Number : 06-8V-CAD3

Device Description : VBR Trial Caddy

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LRP, FSM

Prescription Use : Yes

Device Count : 1

Omnia Medical PsiF - 00843511121266 Catalog Number : 01-5P-ICH2

Device Description : Impaction Cap Handle

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical MainLine - 00843511121273 Catalog Number : 12-6P-INS2

Device Description : Right angled rod inserter

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical Instruments - 00843511121280 Catalog Number : 02-5S-JAM1

Device Description : Bone Access Cannula

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : HXB

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511121761 Catalog Number : 21-5L-INS2

Device Description : Screw inserter

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical PsiF - 00843511121778 Catalog Number : 02-14-N460-BD

Device Description : Kwire, 1.4mm x 460 mm Nitinol, blunt drill

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical Instruments - 00843511121785 Catalog Number : 99-5V-TMP1

Device Description : Cervical Tamp

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical TiBrid SA - 00843511121792 Catalog Number : 17-5A-UJA1

Device Description : universal joint awl

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : HWJ

Prescription Use : Yes

Device Count : 1

Omnia Medical TiBrid SA - 00843511121808 Catalog Number : 17-5A-UJD1

Device Description : Universal Joint Driver

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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