Home GUDID 20851546007015 ImmobiLoc
Primary DI 20851546007015
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
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PCT Prostate Immobilizer Rectal Balloon
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PCT Prostate Immobilizer Rectal Balloon Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851546007018 Package GS1 20 In Commercial Distribution 20851546007015 Package GS1 5 In Commercial Distribution 00851546007011 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10851546007018 10851546007018 20851546007015 20851546007015 00851546007011 00851546007011 851546007011 0851546007011
GMDN Terms# Term, Definition table Term Definition Rectosphincteric balloon A 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 Type Low High Condition Storage Environment Temperature -30 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 005744772 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08715669008770 Push braces Nea International B.V. PCT 2022-12-02 08715669008787 Push braces Nea International B.V. PCT 2022-12-02 08715669008794 Push braces Nea International B.V. PCT 2022-12-02 08715669008800 Push braces Nea International B.V. PCT 2022-12-02 08715669008817 Push braces Nea International B.V. PCT 2022-12-02 08715669002976 Push braces Nea International B.V. PCT 2022-11-04 08715669002983 Push braces Nea International B.V. PCT 2022-11-04 08715669002990 Push braces Nea International B.V. PCT 2022-11-04 08715669003003 Push braces Nea International B.V. PCT 2022-11-04 08715669003010 Push braces Nea International B.V. PCT 2022-11-04 08715669003027 Push braces Nea International B.V. PCT 2022-11-04 08715669003034 Push braces Nea International B.V. PCT 2022-11-04 08715669008893 Push Sports braces Nea International B.V. PCT 2022-10-18 08715669002969 Push braces Nea International B.V. PCT 2022-10-11 08719326258263 QLRAD QLRAD INTERNATIONAL LTD PCT 2021-09-14 08719326258256 QLRAD QLRAD INTERNATIONAL LTD PCT 2021-09-14 08719326258287 QLRAD QLRAD INTERNATIONAL LTD PCT 2021-09-14 08719326258201 QLRAD QLRAD INTERNATIONAL LTD PCT 2020-09-28 08719326258218 QLRAD QLRAD INTERNATIONAL LTD PCT 2020-09-28 10860005263100 Prostate Caddy Rectal Balloon Myriad Medical, LLC PCT 2020-09-23 10860005263117 Prostate Caddy Rectal Balloon Myriad Medical, LLC PCT 2020-09-23 10860005263124 Prostate Caddy Rectal Balloon Myriad Medical, LLC PCT 2020-09-23 00860005263103 Prostate Caddy Rectal Balloon Myriad Medical, LLC PCT 2020-09-23 00860005263110 Prostate Caddy Rectal Balloon Myriad Medical, LLC PCT 2020-09-23 00860005263127 Prostate Caddy Rectal Balloon Myriad Medical, LLC PCT 2020-09-23 00851546007103 IsoLoc RADIADYNE, L.L.C. PCT 2018-01-31 00851546007219 IsoLoc RADIADYNE, L.L.C. PCT 2018-01-31 20851546007091 IsoLoc RADIADYNE, L.L.C. PCT 2018-01-31 00851546007092 IsoLoc RADIADYNE, L.L.C. PCT 2018-01-31 20851546007107 IsoLoc RADIADYNE, L.L.C. PCT 2018-01-31
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