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- Catalog Number : ROSAS00315

Device Description : POINTER PROBE (V3)instrument Rosa 3.0instrument Rosa 3.1Mechanical probe for loc POINTER PROBE (V3)instrument Rosa 3.0instrument Rosa 3.1Mechanical probe for location of anatomical structures or landmarks during neuronavigation

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : ROSAS00316

Device Description : OPTICAL DISTANCE SENSOR (V3)instrument Rosa 3.0Instrument ROSA One 3.1Optical di OPTICAL DISTANCE SENSOR (V3)instrument Rosa 3.0Instrument ROSA One 3.1Optical distance sensor for contactless location of anatomical structures or landmarks. Used for markerless automatic registration and free-hand navigation

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Device Description : Trnsnsl Endscp Rnd Ø3.9mm Holderinstrument Rosa 3.1 (Brain application)instrumen Trnsnsl Endscp Rnd Ø3.9mm Holderinstrument Rosa 3.1 (Brain application)instrument holder for guidance of a Storz sheath 28164 CAA-CFK during endonasal procedures, positioned by the robot arm in accordance with pre- operative plan

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Device Description : Trnsnsl Endscp Ovoid Ø6.18mm Holderinstrument Rosa 3.1 (Brain application)instru Trnsnsl Endscp Ovoid Ø6.18mm Holderinstrument Rosa 3.1 (Brain application)instrument holder for guidance of a Storz sheath 7230 AS-AES during endonasal procedures, positioned by the robot arm in accordance with pre- operative plan

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Device Description : instrument Rosa 3.0instrument Rosa 3.1Alpha Omega microdrive holder

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Device Description : Trnsnsl Endscp Rnd Ø5.1mm Holderinstrument Rosa 3.0instrument Rosa 3.1instrument Trnsnsl Endscp Rnd Ø5.1mm Holderinstrument Rosa 3.0instrument Rosa 3.1instrument holder for guidance of a Storz sheath 28164 ASA-CBF during endonasal procedures, positioned by the robot arm in accordance with pre- operative plan

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : ROSAS00321

Device Description : CRW FRAME ADAPTORinstrument Rosa 3.0instrument Rosa 3.1Mechanical adaptor to con CRW FRAME ADAPTORinstrument Rosa 3.0instrument Rosa 3.1Mechanical adaptor to connect the support arm to the CRW stereotactic frame. Supplied with 8 mm hexagonal key

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Device Description : INOMED MICRODRIVE HOLDER (ZD/RM 590071)instrument Rosa 3.0instrument ROSA 3.1Ino INOMED MICRODRIVE HOLDER (ZD/RM 590071)instrument Rosa 3.0instrument ROSA 3.1Inomed microdrive (for ZD adaptor 590071) supplied with M5 x 10 wing out

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : ROSAS00323

Device Description : RADIOLUCENT SUPPORT ARMinstrument Rosa 3.0instrument Rosa 3.1Radiolucent support RADIOLUCENT SUPPORT ARMinstrument Rosa 3.0instrument Rosa 3.1Radiolucent support arm for rigid fixation of the robot stand to a neurosurgical head holder (mayfield and PMI DORO) or stereotactic frame (leksell) with adaptors.

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Device Description : MAYFIELD HEAD HOLDER ADAPTORinstrument Rosa 3.0Mayfiled head holder mechanical a MAYFIELD HEAD HOLDER ADAPTORinstrument Rosa 3.0Mayfiled head holder mechanical adaptor to connect the support arm to a mayfiled head holder

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1