Home GUDID 07350007951045 Raypilot Hypocath
Primary DI 07350007951045
Brand Raypilot Hypocath
Company Micropos Medical AB (Publ)
Model 1
Catalog number 1004
Device description Raypilot Hypocath is inteded for real time localization of a target during radiation therapy for men with prostate cancer. It is a Foley catheter with a transmitter inserted in one of the lumens. The catheter ensures urine drainage through the duration of the radiation therapy.
Published 2023-04-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name IYE Accelerator, Linear, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYE Accelerator, Linear, Medical Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07350007951540 Package GS1 10 In Commercial Distribution 07350007951045 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07350007951540 07350007951540 7350007951540 07350007951045 07350007951045 7350007951045
GMDN Terms# Term, Definition table Term Definition Radiation therapy lesion localization urethral catheter, procedural A flexible tube with an electrically-powered localization marker [e.g., electromagnetic (EM) transmitter] at its distal end intended to be introduced into the prostatic urethra, to create an identifying mark, for the alignment and monitoring of a patient's tumour/lesion position relative to the isocenter of a radiation therapy system during a therapeutic procedure. It may allow urinary drainage or incorporate a balloon for stabilization. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 350533316 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 false 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 00840277411815 Gold Marker RIVERPOINT MEDICAL, LLC IYE 2026-03-11 00850002461343 BiomarC® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850002461350 Carbon Bright ® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850016008176 VeraForm Viscus Biologics LLC IYE 2024-01-16 07340145700421 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700445 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700506 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700582 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700643 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700667 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701060 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701084 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701107 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701121 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701145 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701169 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701183 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701206 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701220 Gold Anchor Naslund Medical AB IYE 2023-01-23 B887001062 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B887001067 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B8870010010 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010020 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010030 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010070 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010080 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010090 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010210 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010220 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010230 X-MARK Izi Medical Products, LLC IYE 2022-06-17
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