Photon Quad Wedge Plate

Basic Information

• Brand Name: Photon Quad Wedge Plate
• Primary DI: 05060608880669
• Version / Model: 1122655Z
• Catalog Number: 1122655Z
• Company Name: SUN NUCLEAR CORP.
• Labeler DUNS: 122240021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-16
• Public Version: 1
• Public Version Date: 2019-07-24
• Public Version Status: New
• Public Device Record Key: f6d1152b-7c47-4f5c-bea5-fbe36d3665a6

Device Description

Accessory to the Model 1122 IC PROFILER. Used for photon energy measurements.

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	892.1940	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38399	Accelerator system quality assurance device	An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060608880669	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: When not in use, store the Quad Wedge Plate in a climate-controlled environment on a flat surface to minimize deformation of the plate.