Home GUDID 07350007951052 Raypilot Viewcath
Primary DI 07350007951052
Brand Raypilot Viewcath
Company Micropos Medical AB (Publ)
Model 1
Catalog number 1005
Device description Raypilot Viewcath is a Foley catheter (a sterile single-use) for treatment planning prior to radiation therapy for men with prostate cancer.
Published 2023-04-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 07350007951557 Package GS1 10 In Commercial Distribution 07350007951052 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07350007951557 07350007951557 7350007951557 07350007951052 07350007951052 7350007951052
GMDN Terms# Term, Definition table Term Definition Radiation therapy lesion localization urethral catheter, planning A flexible tube with a non-powered radiopaque marker (e.g., barium) 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 isocentre of a radiation therapy system during treatment planning. 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# 
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