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 - 05060201560340 Catalog Number : OHS2062SU

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

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : JDX, LZV

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560357 Catalog Number : OHP2062SU

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

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560364 Catalog Number : OHP2100SU

Device Description : Single Use 10mm Piercer Probe – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560371 Catalog Number : OHS2100SU

Device Description : Single use 10mm Scraper Probe - 80mm – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560388 Catalog Number : OHA2030SU

Device Description : Single Use Acetabular Probe – Sterile

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560395 Catalog Number : OHR2000

Device Description : Reducer Bar for OHP218FSU

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560425 Catalog Number : OS3000

Device Description : Ultrasonic Generator

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560432 Catalog Number : OH300/2

Device Description : Cement Removal Handset

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560449 Catalog Number : OHB300/2

Device Description : Bonecutter Osteotome Handset

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

OSCAR - 05060201560456 Catalog Number : CH300

Device Description : Cable

Device Class : 2

Duns Number: 505987040

Premarket Exempt : No

Product Code : LZV, JDX

Prescription Use : Yes

Device Count : 1

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