FDA.reportPublic FDA data

Navident Accessory Kit

Primary DI
07540209955037
Brand
Navident Accessory Kit
Company
Claronav Inc
Model
955-ND-ACCK
Device description
Navident accessory kit for use with Navident System
Published
2018-04-03
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
PLVDental Stereotaxic Instrument
QRYDental Navigation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLVDental Stereotaxic InstrumentDental2
QRYDental Navigation SystemDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161406000
K210947000
K233563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161406000NavidentClaronav, Inc.2016-09-08PLV
K210947000NavidentClaronav, Inc.2022-06-27PLV
K233563000NavidentClaronav, Inc.2024-07-25PLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540209955037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540209955037075402099550377540209955037

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

Regulatory Flags#

DUNS number
207008769
Device count
1
Kit
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540209957482MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-02026-02-10
07540209957499MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-12026-02-10
07540209957505MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-22026-02-10
07540209957512MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-32026-02-10
07540209957529MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-42026-02-10
07540209957536MicronMapper955-MME-SS16-BDY955-MME-SS16-BDY2026-02-10
07540209957543MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-02026-02-10
07540209957550MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-12026-02-10
07540209957567MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-22026-02-10
07540209957574MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-32026-02-10
07540209957581MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-42026-02-10
07540209957604MicronMapper950-MM1-SLOC-BDY950-MM1-SLOC-BDY2026-02-10
07540209957611MicronMapper950-MM1-SS14-BSE950-MM1-SS14-BSE-82026-02-10
07540209957628MicronMapper950-MM1-SS14-BSE950-MM1-SS14-BSE-162026-02-10
07540209957635MicronMapper950-MM1-SS16-BSE950-MM1-SS16-BSE-82026-02-10
07540209957642MicronMapper950-MM1-SS16-BSE950-MM1-SS16-BSE-162026-02-10
07540209957659MicronMapper950-MM1-SMNI-BSE950-MM1-SMNI-BSE2026-02-10
07540209957666MicronMapper EVO955-MME-ESSM-ASY955-MME-ESSM-ASY-C2026-02-10
07540209956584MicronMapper955-MM1-SPLT-BDY955-MM1-SPLT-BDY-12025-03-03
07540209956591MicronMapper955-MM1-SPLT-BDY955-MM1-SPLT-BDY-22025-03-03

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Primary DI, Brand, Company table
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00810004900653Yomi S Intra Oral Fiducial Array SmallNEOCIS INCPLV2025-12-01
00810004900660Yomi S Intra Oral Fiducial Array MediumNEOCIS INCPLV2025-12-01
00810004900677Yomi S Intra Oral Fiducial Array LargeNEOCIS INCPLV2025-12-01
00810004900684Yomi S YomiLink Teeth Posterior LLURNEOCIS INCPLV2025-12-01
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00810004900707Yomi S YomiLink Arch LLURNEOCIS INCPLV2025-12-01
00810004900714Yomi S YomiLink Arch LRULNEOCIS INCPLV2025-12-01
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00810004900738Yomi S YomiLink Teeth Anterior LRULNEOCIS INCPLV2025-12-01
00810004900745Yomi S YomiLink Bone Lower LLNEOCIS INCPLV2025-12-01
00810004900752Yomi S YomiLink Bone Lower LRNEOCIS INCPLV2025-12-01
00810004900769Yomi S YomiLink Bone Upper ULNEOCIS INCPLV2025-12-01
00810004900776Yomi S YomiLink Bone (U) Assembly (UR)NEOCIS INCPLV2025-12-01
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCPLV2025-12-01
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCQRY2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCPLV2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCQRY2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCQRY2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCPLV2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCPLV2025-12-01
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00810004900820Yomi S Draping KitNEOCIS INCPLV2025-12-01
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00810004900622Neocis Guidance SystemNEOCIS INCQRY2025-05-02
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