OrthAlign Plus

Basic Information

• Brand Name: OrthAlign Plus
• Primary DI: 00810832031987
• Version / Model: 403001-08-US
• Catalog Number: 403001-08-US
• Company Name: ORTHALIGN, INC.
• Labeler DUNS: 023266163
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-26
• Public Version: 1
• Public Version Date: 2023-08-03
• Public Version Status: New
• Public Device Record Key: db7c1054-86e9-4e4f-84cf-b93b7005d8ab

Device Description

OrthAlign Plus Unit - Gap Balancing (US)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810832031987	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Type: Storage Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 60 – 101 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity