Home GUDID 00817740021017 BIONIX RADIATION THERAPY
Primary DI 00817740021017
Brand BIONIX RADIATION THERAPY
Company Bionix Radiation Therapy, LLC
Model ERB-90-FS
Catalog number ERB-90-FS
Device description ENDORECTAL BALLOON
Published 2017-04-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 10817740021014 Package GS1 12 Not in Commercial Distribution 00817740021017 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 10817740021014 10817740021014 00817740021017 00817740021017 817740021017 0817740021017
GMDN Terms# Term, Definition table Term Definition Prostate immobilization balloon catheter A non-sterile flexible tube with an inflatable balloon at its distal end intended to be inserted into the rectum to facilitate adequate positioning and immobilization of the prostate during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Length 90 Millimeter Outer Diameter 41.5 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 STORE IN A COOL, DRY ENVIRONMENT
Regulatory Flags# DUNS number 080397923 Device count 1 DM exempt true Lot or batch true Expiration date on label true 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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