MOLDCARE RI II

Basic Information

• Brand Name: MOLDCARE RI II
• Primary DI: 04900070937410
• Version / Model: HN 1
• Catalog Number: 93741
• Company Name: ALCARE CO., LTD.
• Labeler DUNS: 691371108
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-16
• Public Version: 1
• Public Version Date: 2023-04-24
• Public Version Status: New
• Public Device Record Key: 8c627acf-2a76-4f04-a036-6dac5614f322

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KHX	Platform, Force-Measuring	Physical Medicine	890.1575	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61131	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24900070937414	GS1		50	In Commercial Distribution
Primary	04900070937410	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	20	Centimeter
Width	25	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if the packages is dameged