Alta™

Basic Information

• Brand Name: Alta™
• Primary DI: 10841962110966
• Version / Model: RT-4800-01
• Catalog Number: RT-4800-01
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-04
• Public Version: 3
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: aef91be5-6d4a-44b0-ad36-4c9fb7ec2248

Device Description

Alta™ Multipurpose Device

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	892.5050	2
JAI	Couch, Radiation Therapy, Powered	Radiology	892.5770	2
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2
KPS	System, Tomography, Computed, Emission	Radiology	892.1200	2
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	892.1200	2
FRZ	Device, Patient Transfer, Powered	General Hospital	880.6775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61129	Patient positioner base plate	A device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841962110966	GS1

Customer Contacts

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