FDA.reportPublic FDA data

Bayonet Probe

Primary DI
07540209955143
Brand
Bayonet Probe
Company
ClaroNav Kolahi Inc
Model
950-NE-BP
Device description
Bayonet Probe for Navient
Published
2025-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540209955143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540209955143075402099551437540209955143

GMDN Terms#

Term, Definition table
TermDefinition
Neurological 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 neurosurgery. 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
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
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
07540209955501Navient System with kits955-NC-NC2025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00889024663282PLANNING STATION - ROSA ONE - USAMEDTECHHAW2024-02-20
00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECHHAW2022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244035127PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECHHAW2022-02-18
03760244032195Optical distance sensorMEDTECHHAW2021-06-15
03760244034304ROBOT ROSA ONE (USA)MEDTECHHAW2021-05-31
03760244034403PLANNING STATION Rosa One -USAMEDTECHHAW2021-05-31
04056481143503Kick 2 Navigation StationBrainlab SEHAW2021-05-31
03760244030962CRW frame adaptorMEDTECHHAW2020-11-20
03760244031914LEKSELL FRAME REGISTRATION PLATESMEDTECHHAW2020-10-20