ImmobiLoc

Primary DI
00851546007011
Brand
ImmobiLoc
Company
RADIADYNE, L.L.C.
Model
IL-60
Catalog number
IL-60
Device description
ImmobiLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
Published
2016-09-12
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
PCTProstate Immobilizer Rectal Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCTProstate Immobilizer Rectal BalloonRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130036000PROSTATE IMMOBILIZER RECTAL BALLOONRadiadyne2014-01-28PCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851546007018PackageGS120In Commercial Distribution
20851546007015PackageGS15In Commercial Distribution
00851546007011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154600701810851546007018
2085154600701520851546007015
00851546007011008515460070118515460070110851546007011

GMDN Terms#

Term, Definition table
TermDefinition
Rectosphincteric balloonA hollow rubber structure, expandable with either liquid or air, used in conjunction with a manometer to assess anorectal function (anorectal manometry), typically to evaluate the rectosphincteric reflex upon balloon dilation. The device is typically used in the investigation of lower bowel disorders such as faecal incontinence or Hirschsprung's disease (HD). This is a single-use device.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
281-759-9600leahoe@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
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
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
00851546007103IsoLocRADIADYNE, L.L.C.PCT2018-01-31
00851546007219IsoLocRADIADYNE, L.L.C.PCT2018-01-31
20851546007091IsoLocRADIADYNE, L.L.C.PCT2018-01-31
00851546007092IsoLocRADIADYNE, L.L.C.PCT2018-01-31
20851546007107IsoLocRADIADYNE, L.L.C.PCT2018-01-31