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

Screw, Fixation, Bone (HWC) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

Yes No

Clear

Omnia Medical Golden Spike - 00843511100803 Catalog Number : OM-TLS4036

Device Description : 4.0 x 36mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511100810 Catalog Number : OM-TLS4038

Device Description : 4.0 x 38mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511100827 Catalog Number : OM-TLS4040

Device Description : 4.0 x 40mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511100834 Catalog Number : OM-TLS4042

Device Description : 4.0 x 42mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511100841 Catalog Number : OM-TLS4044

Device Description : 4.0 x 44mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511100858 Catalog Number : OM-TLS4046

Device Description : 4.0 x 46mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511100865 Catalog Number : OM-TLS4048

Device Description : 4.0 x 48mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical Golden Spike - 00843511100872 Catalog Number : OM-TLS4050

Device Description : 4.0 x 50mm Trauma Screw

Device Class : 2

Duns Number: 079467378

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Omnia Medical PsiF - 00843511100889 Catalog Number : 01-5P-MAL1

Device Description : PsiF Mallet Instrument

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Omnia Medical PsiF - 00843511100896 Catalog Number : 01-01-0004

Device Description : PsiF Twist Drill

Device Class : 1

Duns Number: 079467378

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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