FDA.reportPublic FDA data

Electron microPSD

Primary DI
00851546007615
Brand
Electron microPSD
Company
RADIADYNE, L.L.C.
Model
PSD-EE5N
Catalog number
PSD-EE5N
Device description
Electron non-sterile microPSD sensor cable
Published
2019-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZTDosimeter, Ionizing Radiation, Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZTDosimeter, Ionizing Radiation, ImplantedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851546007612PackageGS14In Commercial Distribution
20851546007619PackageGS132In Commercial Distribution
00851546007615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154600761210851546007612
2085154600761920851546007619
00851546007615008515460076158515460076150851546007615

GMDN Terms#

Term, Definition table
TermDefinition
MOSFET radiation therapy dosimetry system dosimeterA 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.

Contacts#

Phone, Email table
PhoneEmail
2817599600sabrinamartilla@radiadyne.com

Regulatory Flags#

DUNS number
005744772
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851546007011ImmobiLocIL-60IL-602016-09-12
00851546007028ImmobiLocIL-100IL-1002016-09-12
00851546007035ImmobiLocILG-60FILG-60F2016-09-12
00851546007042ImmobiLocILG-60F-60mlILG-60F060ml2016-09-12
00851546007059ImmobiLocILG-90FILG-90F2016-09-12
00851546007066OARtracORB-60FORB-60F2016-09-22
00851546007073OARtracOT1-PSD-2UOT1-PSD-2U2016-09-23
00851546007103IsoLocISO-100ISO-1002018-01-31
00851546007141Photon MicroPSDPSD-PE5NPSD-PE5N2018-03-23
00851546007165QC microPSDPSD-QC5NPSD-QC5N2019-06-06
00851546007219IsoLocISO-60ISO-602018-01-31
00851546007417Photon microPSDPSD-PE5NPSD-PE5N2018-05-08
00851546007516QC microPSDPSD-QE5NPSD-QE5N2018-05-08
20851546007091IsoLocISO-60ISO-602018-01-31
00851546007196OARtrac OT-CDU2POT-CDU2P2019-07-03
00851546007004AlatusALA-45 Unit TrayALA-452016-09-12
00851546007080OARtracOT-CDUOT-CDU2016-09-23
00851546007097OARtracOT-PSSOT-PSS2016-09-23
00851546007158QC MicroPSDPSD-QE5NPSD-QE5N2018-03-23
00851546007714HDR microPSDPSD-HB5NPSD-HB5N2018-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851546007196OARtrac RADIADYNE, L.L.C.NZT2019-07-03
00851546007165QC microPSDRADIADYNE, L.L.C.NZT2019-06-06
20851546007169QC microPSDRADIADYNE, L.L.C.NZT2019-06-06
20851546007619Electron microPSDRADIADYNE, L.L.C.NZT2019-05-22
00851546007417Photon microPSDRADIADYNE, L.L.C.NZT2018-05-08
00851546007516QC microPSDRADIADYNE, L.L.C.NZT2018-05-08
20851546007435Photon microPSDRADIADYNE, L.L.C.NZT2018-05-08
20851546007534QC microPSDRADIADYNE, L.L.C.NZT2018-05-08
00851546007714HDR microPSDRADIADYNE, L.L.C.NZT2018-05-08
00851546007141Photon MicroPSDRADIADYNE, L.L.C.NZT2018-03-23
20851546007145Photon MicroPSDRADIADYNE, L.L.C.NZT2018-03-23
00851546007158QC MicroPSDRADIADYNE, L.L.C.NZT2018-03-23
00851546007073OARtracRADIADYNE, L.L.C.NZT2016-09-23
20851546007077OARtracRADIADYNE, L.L.C.NZT2016-09-23
00851546007080OARtracRADIADYNE, L.L.C.NZT2016-09-23
00851546007097OARtracRADIADYNE, L.L.C.NZT2016-09-23
00851546007066OARtracRADIADYNE, L.L.C.NZT2016-09-22
20851546007060OARtracRADIADYNE, L.L.C.NZT2016-09-22