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Raycast® High Precision – Thermoplastic Bolus Material
EUDAMEDFDA UDIClass I (EU MDR)
Ref 703011/1Model 0028Ref 8336.SO1/R/53
Identity
- Trade Name
- Raycast® High Precision – Thermoplastic Bolus Material EUDAMEDOrfit Industries FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- Raycast® High Precision – Thermoplastic Bolus Material EUDAMEDBolus Sheet Beige 10 cm x 10 cm x 5 mm - No Perfo FDA UDI
- Model / Reference
- 0028 EUDAMED703011/1 EUDAMED8336.SO1/R/53 EUDAMEDFDA UDI
- Description
- Bolus Sheet Beige 10 cm x 10 cm x 5 mm - No Perfo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05420028725788 EUDAMED05420028751176 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200287002858 EUDAMED
- Direct Marketing DI
- 05420028725788 EUDAMED05420028751176 EUDAMED
- 510(k) Number
- K991319 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- T030401 RADIOTHERAPY PROTECTION MASKS EUDAMED
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Raycast® High Precision – Thermoplastic Bolus Material by Orfit Industries — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 54200287002858 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orfit Industries
- EUDAMED SRN
- BE-MF-000007872
Sources (3)
- EUDAMED 2bfd487b-b292-496f-bcbd-ad331b1efa06 61 fields · synced Jul 22, 2026
- EUDAMED 7959518f-348c-4eac-aeb1-5a64462d1e5f 61 fields · synced May 19, 2026
- FDA UDI 76fd4b30-9505-4797-9478-a89a8b025b41 35 fields · synced May 30, 2026