FDA.reportPublic FDA data

VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER

Primary DI
03760244031952
Brand
VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER
Company
MEDTECH
Model
174114-01
Catalog number
ROSAS00351
Device description
"""VENTRICULAR ENDOSCOPY INSTRUMENT HOLDERinstrument Rosa One 3.1 (brain application)instrument holder for guidance of neurosurgical endoscope during ventricular procedures through instrument adaptors to accomodate specific endoscope models, positionned by the robot arm in accordance with pre-operative plan."""
Published
2020-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
03760244031952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760244031952037602440319523760244031952

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

Contacts#

Phone, Email table
PhoneEmail
1-800-348-2759product.experience@zimmerbiomet.com

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07340201501887Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2025-03-31
10381780542278CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
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G076A012354A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500578N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327503265N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
10603295522850VELYSDEPUY (IRELAND)HAW2021-07-30
07613327413076n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413090n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413205n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
10603295493624SIGMADEPUY ORTHOPAEDICS, INC.HAW2018-04-19
10650551098277PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2018-01-28
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252252CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
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10381780252399Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
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