Omni Life Science, Inc.

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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

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED (LPH) (10) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (LZO) (9) Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate (MEH) (9)

Premarket Exempt

Clear

OMNI Interface Acetabular System - 00841690100553 Catalog Number : 434128

Device Description : Acetabular Insert, C/28, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH, MEH, LZO

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100560 Catalog Number : 434132

Device Description : Acetabular Insert, C/32, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH, MEH, LZO

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100577 Catalog Number : 434428

Device Description : Acetabular Insert, D/28, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH, MEH, LZO

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100584 Catalog Number : 434432

Device Description : Acetabular Insert, D/32, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LZO, LPH, MEH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100591 Catalog Number : 434828

Device Description : Acetabular Insert, E/28, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH, LZO, MEH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100607 Catalog Number : 434832

Device Description : Acetabular Insert, E/32, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH, MEH, LZO

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100614 Catalog Number : 434836

Device Description : Acetabular Insert, E/36, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : MEH, LPH, LZO

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100621 Catalog Number : 435228

Device Description : Acetabular Insert, F/28, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100638 Catalog Number : 435232

Device Description : Acetabular Insert, F/32, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : MEH, LPH, LZO

Prescription Use : Yes

Device Count : 1

OMNI Interface Acetabular System - 00841690100645 Catalog Number : 435236

Device Description : Acetabular Insert, F/36, 10 degree

Device Class : 2

Duns Number: 061339651

Premarket Exempt : No

Product Code : LZO, MEH, LPH

Prescription Use : Yes

Device Count : 1

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