Navident Accessory Kit

GUDID 07540209955037

Navident accessory kit for use with Navident System

Claronav Inc

Surgical planning/navigation-enhancement system
Primary Device ID07540209955037
NIH Device Record Keyc44f5a6c-e72e-4e71-9c0d-1a8edfc03915
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavident Accessory Kit
Version Model Number955-ND-ACCK
Company DUNS207008769
Company NameClaronav Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540209955037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLVDental Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-03

Devices Manufactured by Claronav Inc

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07540209956263 - MicronMapper EVO2024-05-15 MicronMapper EVO (Full System), including: MicronMapper Software and MicronMapper EVO Scan Bodies. To be used in combination wit
07540209955952 - Navident2024-03-04 Handpiece Tracker (HPT)
07540209956218 - MicronMapper2023-11-14 MicronMapper Optical Dental Metrology System
07540209956225 - MicronMapper2023-11-14 Set of 10 Scan Bodies with autoclavable container

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