Home GUDID 17290019120091 PathKeeper System
Primary DI 17290019120091
Brand PathKeeper System
Company PATHKEEPER SURGICAL LTD
Model TPL0001-01
Published 2023-04-23
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name OLO Orthopedic Stereotaxic Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290019120091 Package GS1 1 In Commercial Distribution 07290019120094 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17290019120091 17290019120091 07290019120094 07290019120094 7290019120094
GMDN Terms# Term, Definition table Term Definition Optical surgical navigation device tracking system A mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/localizers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].
Regulatory Flags# DUNS number 532374343 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M719GL201TL0 SIros-X Genesys Orthopedics Systems LLC OLO 2026-07-23 00840466901035 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901479 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901486 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901493 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901509 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901516 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901523 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901530 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901547 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901554 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901561 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901578 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901585 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901592 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901608 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21 00840466901615 Primus SPINAL ELEMENTS, INC. OLO 2026-07-21