Home GUDID 08719326258218
QLRAD
Primary DI 08719326258218
Brand QLRAD
Company QLRAD INTERNATIONAL LTD
Model 105.1014
Device description RectalPro75
Published 2020-09-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
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 08719326258218 Package GS1 100 In Commercial Distribution 08719326258225 Package GS1 50 In Commercial Distribution 08719326258232 Package GS1 100 In Commercial Distribution 08719326258249 Package GS1 2 In Commercial Distribution 08719326258201 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08719326258218 08719326258218 8719326258218 08719326258225 08719326258225 8719326258225 08719326258232 08719326258232 8719326258232 08719326258249 08719326258249 8719326258249 08719326258201 08719326258201 8719326258201
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.
Regulatory Flags# DUNS number 534509598 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number true Contains natural rubber latex false No natural rubber latex false 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 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 20851546007213 IsoLoc RADIADYNE, L.L.C. PCT 2018-01-31