FDA.reportPublic FDA data

NaviENT system with Kit

Primary DI
07540209955112
Brand
NaviENT system with Kit
Company
ClaroNav Kolahi Inc
Model
955-NE-NE
Device description
Navient ENT system with kit
Published
2025-02-26
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
K163439000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540209955112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540209955112075402099551127540209955112

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius45 Degrees Celsius

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
00824846012832StealthMEDTRONIC NAVIGATION, INC.HAW2026-10-30
00850088866018CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866025CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866032CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866049CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866056CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866063CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866070CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866087CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866094CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866100CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866117CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866124CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866131CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866148CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866155CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866162CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866179CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866186CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866193CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866209CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866216CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866223CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866230CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866247CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866254CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866261CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866278CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866285CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866292CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29