AccessGUDID - DEVICE: MOLDCARE RI II (04900070945118)

GUDID

Device Identifier (DI) Information

Brand Name: MOLDCARE RI II
Version or Model: HN U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 94511
Company Name: ALCARE CO., LTD.

Primary DI Number: 04900070945118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691371108 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHX	Platform, Force-Measuring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Do not use if the packages is dameged

Clinically Relevant Size

[?]

Size Type Text
Length: 35 Centimeter
Width: 20 Centimeter

Device Record Status

Public Device Record Key: 3c63a1b3-9642-4018-96de-5c9684414b9b
Public Version Date: May 30, 2024
Public Version Number: 2
DI Record Publish Date: April 16, 2023