Home GUDID 00850028694152 HOLO Portal
Primary DI 00850028694152
Brand HOLO Portal
Company Surgalign Spine Technologies, Inc.
Model 154000077
Device description ICT PAK Alignment Insert
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 00850028694152 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 00850028694152 00850028694152 850028694152 0850028694152
GMDN Terms# Term, Definition table Term Definition Multi-purpose stereotactic surgery system An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided 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 00763000914097 Stealth AXiS MEDTRONIC NAVIGATION, INC. OLO 2026-07-24 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
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