Navigation Cart

GUDID 04719878713511

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Surgical planning/navigation-enhancement system
Primary Device ID04719878713511
NIH Device Record Keya4de4456-d00e-4ed7-b5a1-06603f4eea3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigation Cart
Version Model NumberCDS-NGC-03
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
GS104719878713511 [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

Devices Manufactured by Taiwan Main Orthopaedic Biotechnology Co., Ltd.

04719878713016 - Disposable Passive Sphere2024-12-11
14719878713112 - Bone Drill2024-12-11
24719878713065 - Caduceus S2024-12-11
04719878713078 - Headset2024-12-10
04719878713085 - Connection System2024-12-10
04719878713207 - Disposable Passive Sphere2024-12-10
04719878713337 - Router2024-12-10
04719878713511 - Navigation Cart2024-12-10
04719878713511 - Navigation Cart2024-12-10

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