MEDTECH

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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

Neurological Stereotaxic Instrument (HAW) (7) Orthopedic Stereotaxic Instrument (OLO) (3)

Premarket Exempt

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STORZ 28160 GM adaptor - 03760244030979 Catalog Number : ROSAS00327

Device Description : Instrument Adaptor 28160 GMENDSCP OVOID 5.3 ADP - PEEKInstrument Rosa One 3.1 (b Instrument Adaptor 28160 GMENDSCP OVOID 5.3 ADP - PEEKInstrument Rosa One 3.1 (brain application)Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ENDSCP NAV INTERFACE (Ø 6,7 mm) - 03760244030986 Catalog Number : ROSAS00179

Device Description : Endscp Nav Interface Ø6.7mmEndoscope navigation interfaceinstrument Rosa one 3.1 Endscp Nav Interface Ø6.7mmEndoscope navigation interfaceinstrument Rosa one 3.1 (spine application)"

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ENDSCP NAV INTERFACE (Ø 6,1 mm) - 03760244031020 Catalog Number : ROSAS00180

Device Description : Endscp Nav Interface Ø6.1mmEndoscope navigation interfaceinstrument Rosa one 3.1 Endscp Nav Interface Ø6.1mmEndoscope navigation interfaceinstrument Rosa one 3.1(spine application)"

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

2D X-RAY LEKSELL FRAME REGST PLATES - 03760244031044 Catalog Number : ROSAS00345

Device Description : 2D X-Ray Leksell Frame Platesinstrument Rosa One 3.1 (brain application)calibrat 2D X-Ray Leksell Frame Platesinstrument Rosa One 3.1 (brain application)calibrated tool for manual registration of the device with the Leksell frame. Mounted on the Leksell stereotactic frame."

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ROSA® Brain - 03760244031051 Catalog Number : ROSAS00303

Device Description : Standard ROSA® BRAIN Surgical Assistant device (including robot arm and stand , Standard ROSA® BRAIN Surgical Assistant device (including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ENDSCP OVOID 6.18 ADP - SST - 03760244031075 Catalog Number : ROSAS00330

Device Description : Instrument Adaptor 7230 AS-AESSTORZ 7230 AS-AES adaptor instrument Rosa One 3.1 Instrument Adaptor 7230 AS-AESSTORZ 7230 AS-AES adaptor instrument Rosa One 3.1 (brain application)Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling"

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STORZ 28160 G ADAPTOR - 03760244031099 Catalog Number : ROSAS00326

Device Description : Instrument Adaptor 28160 Ginstrument Rosa One 3.1 (brain application)Ventricular Instrument Adaptor 28160 Ginstrument Rosa One 3.1 (brain application)Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling"

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

MICRODIVE HOLDER Ø7.95 - 03760244031105 Catalog Number : ROSAS00495

Device Description : Microdrive Ø7.95mm Holderinstrument Rosa One 3.1 (brain application)Mechanical h Microdrive Ø7.95mm Holderinstrument Rosa One 3.1 (brain application)Mechanical holder for microdriveSupplied with 2 M5*10 wing nuts and 1 M4*10 knurled screw

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

MICRODIVE HOLDER Ø18 - 03760244031112 Catalog Number : ROSAS00496

Device Description : Microdrive Ø18mm HolderINOMED Microdrive holder instrument Rosa One 3.1 (brain a Microdrive Ø18mm HolderINOMED Microdrive holder instrument Rosa One 3.1 (brain application)Mechanical holder for microdriveSupplied with 2 M5*10 wing nuts and 1 M4*10 knurled screw

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

AWL Ø4.0MM - 03760244031136 Catalog Number : ROSAS00155

Device Description : Awl Ø4mminstrument Rosa one 3.1 (spine application)Awl for soft tissues dilation "

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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