Patient Tracker SPX1

GUDID 03701311501374

ECENTIAL ROBOTICS

Surgical optical-tracking spatial marker, single-use
Primary Device ID03701311501374
NIH Device Record Key4c3b7903-b7c4-4a84-8ac5-ceac2a7698bd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Tracker SPX1
Version Model NumberA01039
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701311501374 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

Devices Manufactured by ECENTIAL ROBOTICS

03701311500865 - Op.n Tracker A2025-03-28
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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