FDA.reportPublic FDA data

Photon MicroPSD

Primary DI
20851546007145
Brand
Photon MicroPSD
Company
RADIADYNE, L.L.C.
Model
PSD-PE5N
Catalog number
PSD-PE5N
Device description
Photon-calibrated microPSD sensor cable
Published
2018-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

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
10851546007148PackageGS14In Commercial Distribution
20851546007145PackageGS132In Commercial Distribution
00851546007141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154600714810851546007148
2085154600714520851546007145
00851546007141008515460071418515460071410851546007141

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
281-759-9600sabrinamartilla@radiadyne.com

Regulatory Flags#

DUNS number
005744772
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00851546007615Electron microPSDPSD-EE5NPSD-EE5N2019-05-22
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

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
00851546007615Electron microPSDRADIADYNE, L.L.C.NZT2019-05-22
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
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