HOLO Portal

Basic Information

• Brand Name: HOLO Portal
• Primary DI: 00850028694367
• Version / Model: 154000086
• Company Name: Surgalign Spine Technologies, Inc.
• Labeler DUNS: 014520584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-28
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 19350beb-34b2-482e-b024-1ea95a788723

Device Description

PAK Needle Calibration Instrument

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLO	Orthopedic Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45199	Multi-purpose stereotactic surgery system	An electrically-powered 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850028694367	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]