Electron microPSD PSD-EE5N

GUDID 20851546007619

Electron non-sterile microPSD sensor cable

RADIADYNE, L.L.C.

MOSFET radiation therapy dosimetry system dosimeter
Primary Device ID20851546007619
NIH Device Record Key46e05118-be30-46cb-b482-accde1ec5391
Commercial Distribution StatusIn Commercial Distribution
Brand NameElectron microPSD
Version Model NumberPSD-EE5N
Catalog NumberPSD-EE5N
Company DUNS005744772
Company NameRADIADYNE, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2817599600
Emailsabrinamartilla@radiadyne.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851546007615 [Primary]
GS110851546007612 [Package]
Contains: 00851546007615
Package: Shelf Box [4 Units]
In Commercial Distribution
GS120851546007619 [Package]
Contains: 10851546007612
Package: Shipper Box [32 Units]
In Commercial Distribution

FDA Product Code

NZTDosimeter, Ionizing Radiation, Implanted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-30
Device Publish Date2019-05-22

Devices Manufactured by RADIADYNE, L.L.C.

20851546007091 - IsoLoc2020-01-28 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
00851546007196 - OARtrac 2019-07-11 OARtrac Plus Clinical Detector Unit (CDU)
20851546007169 - QC microPSD2019-06-14 QC microPSD sensor cable
20851546007619 - Electron microPSD2019-05-30Electron non-sterile microPSD sensor cable
20851546007619 - Electron microPSD2019-05-30 Electron non-sterile microPSD sensor cable
20851546007107 - IsoLoc2018-07-27 IsoLoc Prostate Immobilization Treatment Balloon Device Kit
20851546007145 - Photon MicroPSD2018-07-27 Photon-calibrated microPSD sensor cable
00851546007158 - QC MicroPSD2018-07-27 QC-calibrated microPSD sensor cable
20851546007213 - IsoLoc2018-07-27 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.