Home GUDID 24900070945129
MOLDCARE RI II
Primary DI 24900070945129
Brand MOLDCARE RI II
Company ALCARE CO., LTD.
Model HN E
Catalog number 94512
Device description Website> https://www.alcare.co.jp/en/medical/product/about_moldcare/ Catalog> https://www.alcare.co.jp/en/assets/images/medical/product/pdf/Moldcare_EN.pdf IFU> https://www.alcare.co.jp/en/assets/images/medical/product/pdf/Moldcare_RI_II_Manual_EN.pdf
Published 2023-04-16
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name KHX Platform, Force-Measuring KXH Cradle, Patient, Radiologic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHX Platform, Force-Measuring Physical Medicine 1 KXH Cradle, Patient, Radiologic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 24900070945129 Package GS1 50 In Commercial Distribution 04900070945125 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 24900070945129 24900070945129 04900070945125 04900070945125 4900070945125
GMDN Terms# Term, Definition table Term Definition Radiological general body-part positioner A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 25 Degrees Celsius Special Storage Condition, Specify 0 0 Do not use if the packages is dameged Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Keep dry Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 691371108 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false 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#