Navi Tracker

GUDID 04719878713542

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Surgical planning/navigation-enhancement system
Primary Device ID04719878713542
NIH Device Record Key02292485-a76b-44e7-aac6-1cfe2a82cde2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavi Tracker
Version Model NumberCDS-NTR-04
Company DUNS658875222
Company NameTaiwan Main Orthopaedic Biotechnology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS104719878713542 [Primary]

FDA Product Code

SBFOrthopedic Augmented Reality

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-10
Device Publish Date2024-12-02

On-Brand Devices [Navi Tracker]

04719878713542CDS-NTR-04
04719878713528CDS-NTR-02

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