Electron microPSD

Basic Information

• Brand Name: Electron microPSD
• Primary DI: 00851546007615
• Version / Model: PSD-EE5N
• Catalog Number: PSD-EE5N
• Company Name: RADIADYNE, L.L.C.
• Labeler DUNS: 005744772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-22
• Public Version: 1
• Public Version Date: 2019-05-30
• Public Version Status: New
• Public Device Record Key: 46e05118-be30-46cb-b482-accde1ec5391

Device Description

Electron non-sterile microPSD sensor cable

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZT	Dosimeter, Ionizing Radiation, Implanted	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60322	MOSFET radiation therapy dosimetry system dosimeter	A non-sterile device using metal oxide semiconductor field-effect transistor (MOSFET) technology that is a component of a MOSFET radiation therapy dosimetry system intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during a radiation therapy and radiology procedure. It consists of a small MOSFET dosimeter (sensor) at its distal end with an electrically-conductive wire proximally that connects to a dosimeter reader for the recording of radiation dose readings. It is typically placed (taped) on the patient in the area of interest for radiation therapy or placed in a catheter for in vivo brachytherapy application. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20851546007619	GS1	Shipper Box	32	In Commercial Distribution
Package	10851546007612	GS1	Shelf Box	4	In Commercial Distribution
Primary	00851546007615	GS1

Customer Contacts

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