FDA.reportPublic FDA data

OARtrac

Primary DI
00851546007066
Brand
OARtrac
Company
RADIADYNE, L.L.C.
Model
ORB-60F
Catalog number
ORB-60F
Device description
OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit, with Fiducial Marker and PSD Sensor Bundle
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZTDosimeter, Ionizing Radiation, Implanted
PCTProstate Immobilizer Rectal Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZTDosimeter, Ionizing Radiation, ImplantedRadiology2
PCTProstate Immobilizer Rectal BalloonRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141154000OARTRAC SYSTEMRadiadyne2014-07-22NZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851546007063PackageGS110In Commercial Distribution
20851546007060PackageGS15In Commercial Distribution
00851546007066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154600706310851546007063
2085154600706020851546007060
00851546007066008515460070668515460070660851546007066

GMDN Terms#

Term, Definition table
TermDefinition
Linear accelerator systemAn assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
005744772
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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
00851546007714HDR microPSDPSD-HB5NPSD-HB5N2018-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08715669008770Push bracesNea International B.V.PCT2022-12-02
08715669008787Push bracesNea International B.V.PCT2022-12-02
08715669008794Push bracesNea International B.V.PCT2022-12-02
08715669008800Push bracesNea International B.V.PCT2022-12-02
08715669008817Push bracesNea International B.V.PCT2022-12-02
08715669002976Push bracesNea International B.V.PCT2022-11-04
08715669002983Push bracesNea International B.V.PCT2022-11-04
08715669002990Push bracesNea International B.V.PCT2022-11-04
08715669003003Push bracesNea International B.V.PCT2022-11-04
08715669003010Push bracesNea International B.V.PCT2022-11-04
08715669003027Push bracesNea International B.V.PCT2022-11-04
08715669003034Push bracesNea International B.V.PCT2022-11-04
08715669008893Push Sports bracesNea International B.V.PCT2022-10-18
08715669002969Push bracesNea International B.V.PCT2022-10-11
08719326258263QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258256QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258287QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258201QLRADQLRAD INTERNATIONAL LTDPCT2020-09-28
08719326258218QLRADQLRAD INTERNATIONAL LTDPCT2020-09-28
10860005263100Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
10860005263117Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
10860005263124Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
00860005263103Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
00860005263110Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
00860005263127Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
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