AccessGUDID - DEVICE: MOLDCARE RI II (04900070930664)

GUDID

Device Identifier (DI) Information

Brand Name: MOLDCARE RI II
Version or Model: HN 0.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 93066
Company Name: ALCARE CO., LTD.

Primary DI Number: 04900070930664
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/

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
KXH	Cradle, Patient, Radiologic

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: 20 Centimeter
Width: 15 Centimeter

Device Record Status

Public Device Record Key: 33076292-92da-4259-b311-59587f69f46c
Public Version Date: June 18, 2025
Public Version Number: 4
DI Record Publish Date: April 16, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24900070930668	50	04900070930664		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 9999999999
Email: inquiry@alcare.co.jp

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