FDA.reportPublic FDA data

INSTRUMENT HOLDER (V3)

Primary DI
03760244031969
Brand
INSTRUMENT HOLDER (V3)
Company
MEDTECH
Model
174113-00
Catalog number
ROSAS00498
Device description
"""INSTRUMENT HOLDER (V3)instrument Rosa One 3.1 (brain application)Mechanical instrument holder for accurate mechanical guidance of neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode) positionned by robot arm in accordance with a pre-operative plan."""
Published
2020-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182417000ROSA ONE Brain ApplicationMedtech S.A2019-02-07HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760244031969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760244031969037602440319693760244031969

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
264502977
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024704213PLANNING STATION - USA164063ROSAS005032026-02-23
03760244034304ROBOT ROSA ONE (USA)3.1.5ROSAS002032021-05-31
03760244033765ROBOT ROSA ONE (USA)3.1.4.0ROSAS002032020-07-17
00889024679559ALLEN WRENCH 8MM151124ROSAS005362025-07-15
00887868539978 SEEG DRILL ADAPTOR 2.70MM174153ROSAS000852025-06-24
00889024663282PLANNING STATION - ROSA ONE - USA164056ROSAS005032024-02-20
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm Holder174008-00ROSAS003182023-10-27
00887868585951ROSA ONE BRAIN APPLICATION (US)3.1.7ROSAS002032023-10-30
03760244034625SEEG DRILL ADAPTOR Ø2.5MM174153ROSAS000802022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MM174153ROSAS000812022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MM174153ROSAS000822022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MM174153ROSAS000832022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MM174153ROSAS000842022-02-18
03760244032195Optical distance sensor174007ROSAS003162021-06-15
03760244030962CRW frame adaptor174010ROSAS003212020-11-20
03760244032218TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3,9 mm174040-01ROSAS003172020-10-20
03760244032294TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5,1 mm174040-01ROSAS003202020-10-20
03760244034069LEKSELL FRAME REGISTRATION PLATES174016-01ROSAS005002020-10-20
03760244030108MEDTRONIC FHC MICRODRIVE HOLDER ROSA-282CROSAS000182016-10-09
037602440310442D X-RAY LEKSELL FRAME REGST PLATES174015ROSAS003452019-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150054466N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00763000381141N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.HAW2026-08-07
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695107Instrument Adaptor (8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695121SEEG AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695145Catheter AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695169Thumb Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695183Set Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695206Pin Screw of Instrument AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695220Catheter Adaptor_3.5mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695244Instrument Adaptor (1.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695268Instrument Adaptor (2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695282Instrument Adaptor (2.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695305Instrument Adaptor (2.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25