FDA.reportPublic FDA data

NaviENT Accessory Kit

Primary DI
07540209955105
Brand
NaviENT Accessory Kit
Company
ClaroNav Kolahi Inc
Model
955-NE-ACCK
Device description
NaviENT Accessory Kit for use with the NaviENT surgical navigation system.
Published
2018-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PGWEar, Nose, And Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163439000NaviENTClaronav, Inc.2017-09-01HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540209955105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540209955105075402099551057540209955105

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203466065
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
07540209955129Frontal Seeker950-NE-FS2025-05-27
07540209955136Maxillary Seeker950-NE-MS2025-05-27
07540209955143Bayonet Probe950-NE-BP2025-05-27
07540209955150Registration Probe950-NE-RP2025-05-27
07540209955167Tip Calibrator950-NE-TP2025-05-27
07540209955181Frontal Seeker B950-NE-FS-B2025-05-27
07540209955198Maxillary Seeker B950-NE-MS-B2025-05-27
07540209955204Bayonet Probe950-NE-BP-B2025-05-27
07540209955211Registration probe B950-NE-RP-B2025-05-27
07540209955259Tip Calibrator B950-NE-TC-B2025-05-27
07540209955266Universal Tracker 1950-NE-UT12025-05-27
07540209955273Universal Tracker 2950-NE-UT22025-05-27
07540209955280Universal tracker 1 B950-NE-UT1-B2025-05-27
07540209955297Universal Tracker 2 B95-NE-UT2-B950-NE-UT2-B2025-05-27
07540209955716Patient Tracker955-NE-PT2025-05-27
07540209956300C-Clamp small950-NE-UTCS2025-05-27
07540209956317C-Clamp medium950-NE-UTCM2025-05-27
07540209956324C-Clamp Large950-NE-UTCL2025-05-27
07540209956331C-Clamp XL950-NE-UTCXL2025-05-27
07540209956348ENT Sterilization Tray950-NE-STE2025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260759931314Flexarm UniversalFiagon GmbHPGW2026-09-20
04260759931697VirtuEye ProFiagon GmbHPGW2026-08-17
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2026-08-07
00199150006427Stealth AXiSMEDTRONIC NAVIGATION, INC.PGW2026-04-24
00763000738358AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738365AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738372AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738389AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738396AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
04056481146702Curve NavigationBrainlab SEPGW2025-10-13
04260759930003Integrated HeadrestFiagon GmbHPGW2025-06-25
04260759930133Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
042607599301574K Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
04260759930249Navigation SensorFiagon GmbHPGW2025-01-16
04260759930300FlexPointerFiagon GmbHPGW2025-01-16
04260759930317FlexPointer 1.5 mmFiagon GmbHPGW2025-01-16
04260759930324FlexTube 3mmFiagon GmbHPGW2025-01-16
04260759930331FlexTube 4mmFiagon GmbHPGW2025-01-16
04260759930348PointerTube KeatFiagon GmbHPGW2025-01-16
04260759930355PointerTube KennedyFiagon GmbHPGW2025-01-16
04260759930447Localizer Adhesive Pad C-TypeFiagon GmbHPGW2025-01-16
04260759930515Adhesive PadFiagon GmbHPGW2024-09-02
04260759930119RegistrationPointerFiagon GmbHPGW2024-09-02
04260759930126VirtuEyeFiagon GmbHPGW2024-09-02
04260759930256Navigation Headrest UniversalFiagon GmbHPGW2024-09-02
04260759930362PointerShell 4 mm Fiagon GmbHPGW2024-09-02
04260759930379PointerShell 5 mm Fiagon GmbHPGW2024-09-02
04260759930386PointerShell 3 mm Fiagon GmbHPGW2024-09-02
04260759930393PointerShell UniversalFiagon GmbHPGW2024-09-02
14260759930512Adhesive PadFiagon GmbHPGW2024-09-02