Op.n Tracker B

GUDID 03701311500872

ECENTIAL ROBOTICS

Surgical optical-tracking spatial marker, reusable
Primary Device ID03701311500872
NIH Device Record Key2c305227-6f27-48be-b5f6-79b2967ff0b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameOp.n Tracker B
Version Model NumberA00064
Company DUNS261610964
Company NameECENTIAL ROBOTICS
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701311500872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


[03701311500872]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

Devices Manufactured by ECENTIAL ROBOTICS

03701311500865 - Op.n Tracker A2025-03-28
03701311500872 - Op.n Tracker B2025-03-28
03701311500872 - Op.n Tracker B2025-03-28
03701311500889 - Op.n Tracker C2025-03-28
03701311500896 - Op.n Tracker D2025-03-28
03701311500902 - Navigation Instrument tray2025-03-28
03701311501275 - Op.n Camera2025-03-28
03701311501282 - Tracker fixation screw2025-03-28
03701311501435 - Op.n Core2025-03-28

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