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) (9)

Premarket Exempt

Clear

OSCAR - 05060201560579 Catalog Number : OHH2081SU

Device Description : Single Use 8mm Hoe Probe – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560586 Catalog Number : OHSO2060SU

Device Description : Single Use 6mm Serrated Osteotome – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560593 Catalog Number : SPAN7MM

Device Description : SPANNER 7MM

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560609 Catalog Number : SPAN8/9MM

Device Description : SPANNER 8/9MM

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560616 Catalog Number : OHG2020SU

Device Description : Single Use 2 Lobed Groover Probe – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560623 Catalog Number : OHRE2002SU

Device Description : Single Use Short Extension Reducer Bar – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560630 Catalog Number : OHRE2003SU

Device Description : Single Use Long Extension Reducer Bar – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560647 Catalog Number : OHB300

Device Description : Oscar II Handset - Bonecutter

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560654 Catalog Number : OHP2061

Device Description : 6mm Piercer Probe - 180mm

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560661 Catalog Number : OHP2081

Device Description : 8mm Piercer Probe - 180mm

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

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