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 - 00843511100001 Catalog Number : 06-0V-1213

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 13mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100018 Catalog Number : 06-0V-1218

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 18mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100025 Catalog Number : 06-0V-1223

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 23mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100032 Catalog Number : 06-0V-1228

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 28mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100049 Catalog Number : 06-0V-1233

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 33mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100056 Catalog Number : 06-0V-1238

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 38mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100063 Catalog Number : 06-0V-1243

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 43mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100070 Catalog Number : 06-0V-1248

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 48mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100087 Catalog Number : 06-0V-1253

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 53mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100094 Catalog Number : 06-0V-1258

Device Description : Omnia Medical VBR, 12mm X 12.5mm X 58mm Tall

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

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