ORTHOSONICS LIMITED

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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

Instrument, Surgical, Sonic And Accessory/Attachment (JDX) (10) System, Cement Removal Extraction (LZV) (10)

Premarket Exempt

Clear

OSCAR - 05060201560463 Catalog Number : ORFS300

Device Description : Footswitch

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560470 Catalog Number : OHRE2001SU

Device Description : Long Extension Reducer Bar for Single Use Probes

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560487 Catalog Number : OHRE2000SU

Device Description : Short Extension Reducer Bar for Single Use Probes

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560494 Catalog Number : O3GC300

Device Description : OSCAR 3 Case (Generator)

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560500 Catalog Number : O3HC300

Device Description : OSCAR 3 Case (Instruments)

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560517 Catalog Number : AO400

Device Description : OSCAR Sterilization Tray

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560531 Catalog Number : OBE2000

Device Description : Bonecutter - Extension Bar

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560548 Catalog Number : OHC2SO2060SU

Device Description : Single Use 6mm Serrated Curved Osteotome – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560555 Catalog Number : OHFO2060SU

Device Description : Single Use 6mm Flat Osteotome – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560562 Catalog Number : OHH2062SU

Device Description : Single Use 6mm Hoe Probe - 180mm – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

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