FDA.reportPublic FDA data

MOLDCARE RI II

Primary DI
04900070942322
Brand
MOLDCARE RI II
Company
ALCARE CO., LTD.
Model
HN TR
Catalog number
94232
Device description
Website> https://www.alcare.co.jp/en/medical/product/about_moldcare/
Published
2023-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHXPlatform, Force-Measuring
KXHCradle, Patient, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHXPlatform, Force-MeasuringPhysical Medicine1
KXHCradle, Patient, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24900070942326PackageGS125In Commercial Distribution
04900070942322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2490007094232624900070942326
04900070942322049000709423224900070942322

GMDN Terms#

Term, Definition table
TermDefinition
Radiological general body-part positionerA 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
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Do not use if the packages is dameged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81356117819info@alcare.co.jp
9999999999inquiry@alcare.co.jp

Regulatory Flags#

DUNS number
691371108
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04900070959412MOLDCARE RI IIHN S959412025-06-24
04900070959429MOLDCARE RI IIHN C959422025-06-24
04900070937410MOLDCARE RI IIHN 1937412023-04-16
04900070937427MOLDCARE RI IIHN 2937422023-04-16
04900070938226MOLDCARE RI IIBR3938222022-11-25
04900070945118MOLDCARE RI IIHN U945112023-04-16
04900070945125MOLDCARE RI IIHN E945122023-04-16
04900070945217MOLDCARE RI IIHN UT945212023-04-16
04900070930664MOLDCARE RI IIHN 0.5930662023-04-16
04900070938219MOLDCARE RI IIBR1938212022-11-22
24900070937414MOLDCARE RI IIHN 1937412023-04-16
24900070937421MOLDCARE RI IIHN 2937422023-04-16
24900070945112MOLDCARE RI IIHN U945112023-04-16
24900070945129MOLDCARE RI IIHN E945122023-04-16
24900070945211MOLDCARE RI IIHN UT945212023-04-16
24900070938220MOLDCARE RI IIBR3938222022-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640178061002ProFoamPearl Technology AGKXH2025-12-17
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