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) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

Yes No

Clear

Omnia Medical PsiF - 00843511100902 Catalog Number : 01-01-0005

Device Description : Orthocision PsiF Box Cutter

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical PsiF - 00843511100919 Catalog Number : 01-01-0011

Device Description : PsiF Slap Hammer

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical VBR - 00843511100926 Catalog Number : 06-5V-TR13

Device Description : 13mm 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 - 00843511100933 Catalog Number : 06-5V-TR15

Device Description : 15mm 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 - 00843511100940 Catalog Number : 06-5V-TR17

Device Description : 17mm 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 - 00843511100957 Catalog Number : 06-5V-TR19

Device Description : 19mm 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 - 00843511100964 Catalog Number : 06-5V-TR21

Device Description : 21mm 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 - 00843511100971 Catalog Number : 06-5V-TR23

Device Description : 23mm 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 - 00843511100988 Catalog Number : 06-5V-TR25

Device Description : 25mm 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 - 00843511100995 Catalog Number : 06-5V-TR27

Device Description : 27mm Omnia Medical VBR Trial

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

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