Varex Imaging

Basic Information

• Brand Name: Varex Imaging
• Primary DI: 08718755001174
• Version / Model: 18893-10
• Company Name: Varex Imaging Nederland B.V.
• Labeler DUNS: 413223942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-02
• Public Version: 2
• Public Version Date: 2021-03-18
• Public Version Status: Update
• Public Device Record Key: d32f2127-28e1-4c04-ba3a-d48d37d7c486

Device Description

This is a set consisting out of an AEC sensor from the SolidStateMC series and an amplifier from AmpMC-series.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	892.1700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38336	Solid-state-semiconductor radiation measuring probe	A device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity and its energy discrimination properties allow it to be incorporated in radiation detection, measurement instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray, high-energy beta particles or neutrons) that can be detected.	No	Active
38339	Multichannel radiation survey meter	A survey meter or area monitor with a spectrometer to separate pulses received from a detector according to pulse size. Pulse size is proportional to energy of the detected radiation. It typically consists of a detector (usually a scintillation or semiconductor detector), a linear amplifier, an analogue-to-digital converter (ADC), a computer memory for storing information from the ADC, a scalar or count rate meter. The memory permits automated data processing, e.g., background subtraction and spectrum striping, which permits the analysis of complex spectra.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718755001174	GS1