FDA UDI
In Commercial Distribution
🇺🇸 United States
MOLDCARE RI II
DI: 04900070937427
·
Model: HN 2
·
ALCARE CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MOLDCARE RI II
- Primary DI
- 04900070937427
- Version / Model
- HN 2
- Catalog Number
- 93742
- 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
- cb2ca199-e4ab-4073-83e9-ea947b8efd0f
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 | 24900070937421 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 04900070937427 | GS1 |
Customer Contacts
- Phone
- +81356117819
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20 | Centimeter | |
| Width | 45 | 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