Alta

Basic Information

• Brand Name: Alta
• Primary DI: 00841962119764
• Version / Model: RT-4800-SR
• Catalog Number: RT-4800-SR
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-09
• Public Version: 1
• Public Version Date: 2025-07-17
• Public Version Status: New
• Public Device Record Key: 87a730b0-4701-431e-91bc-4b398af3f029

Device Description

Shoulder Retractor Strap

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: 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
FRZ	Device, Patient Transfer, Powered	General Hospital	880.6775	2
IYE	Accelerator, Linear, 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
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	892.5050	2
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	892.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61129	Patient positioner base plate	A device in the form of a non-mirrored flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices (not included) 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	00841962119764	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193243	000