Home GUDID 00850028694015 HOLO Portal
Primary DI 00850028694015
Brand HOLO Portal
Company Surgalign Spine Technologies, Inc.
Model 154000017
Device description HOLO AR Mirror Frame, Sterile
Published 2022-04-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 00850028694015 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850028694015 00850028694015 850028694015 0850028694015
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].
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 014520584 Device count 1 Lot or batch true Sterilization required before use true 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
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