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

Spinal Vertebral Body Replacement Device (MQP) (10)

Premarket Exempt

No Yes

Clear

Omnia Medical VBR - 00843511100407 Catalog Number : 06-5V-INS1

Device Description : Omnia Medical VBR, Inserter

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100414 Catalog Number : 06-5V-TRI1

Device Description : Omnia Medical VBR, Trial

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100421 Catalog Number : 06-5V-PAC1

Device Description : Omnia Medical VBR, Graft Packing Block

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100438 Catalog Number : 06-5V-TAM1

Device Description : Omnia Medical VBR, Tamp

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100445 Catalog Number : 06-6V-CAL1

Device Description : Omnia Medical VBR, Calipers

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100452 Catalog Number : 06-6V-MAL1

Device Description : Omnia Medical VBR, Mallet

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100469 Catalog Number : 06-5V-REL1

Device Description : Omnia Medical VBR, Endplate Release Tool

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100476 Catalog Number : 06-8V-CAD1

Device Description : Omnia Medical VBR, 12mm Implant Caddy

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100483 Catalog Number : 06-8V-CAD2

Device Description : Omnia Medical VBR, 14mm Implant Caddy

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100490 Catalog Number : 06-7V-TRA1

Device Description : Omnia Medical VBR, Case

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

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