Navient system

GUDID 07540209955969

Navient system 955-NC-NC

ClaroNav Kolahi Inc

Neurological stereotactic surgery system
Primary Device ID07540209955969
NIH Device Record Keyd88b2e49-0f5a-4321-bce1-0a0a9b57937a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavient system
Version Model Number955-NC-NC
Company DUNS203466065
Company NameClaroNav Kolahi Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS107540209955969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-10
Device Publish Date2025-02-28

Devices Manufactured by ClaroNav Kolahi Inc

07540209955501 - Navient System with kits2025-03-10 Navient System 955-NC-NC with kits
07540209955518 - Navient Accessory kit - cranial2025-03-10 Navient Accessory kit for use with Navient system, cranial
07540209955525 - Navient Accessory kit - biopsy2025-03-10 Navient Accessory kit - biopsy for use with Navient system, cranial
07540209955723 - Universal Tracker Biopsy2025-03-10 Universal Tracker Biopsy for use with Navient system, cranial
07540209955730 - Universal Tracker Cusa2025-03-10 Universal Tracker Cusa for use with Navient system, cranial
07540209955747 - Universal Tracker Stimulation probe2025-03-10 Universal Tracker Stimulation probe for use with Navient system, cranial
07540209955754 - Universal Tracker Suction2025-03-10 Universal Tracker Suction for use with Navient system, cranial
07540209955945 - Navigated Shunt Needle 2025-03-10 Navigated Shunt Needle for use with Navient system, cranial

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