Identity
- Trade Name
- Chabner XRT EUDAMEDFDA UDI
- Generic Name
- Radiological breast positioner, wearable FDA UDI
- Device Name
- Chabner XRT Radiation Bra EUDAMEDThe Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and radiation treatment, including proton therapy. The bra can also be used for breast support during other radiologic procedures such as CT, MRI and diagnostic X-rays. The bra, customizable for a wide variety of body types, is made of lightweight, advanced materials providing enhanced support ideal for positioning the breast and ensuring patient comfort without irritation or sensitization. FDA UDI
- Model / Reference
- CRTBRA EUDAMEDCRTBRA01 EUDAMEDFDA UDI
- Description
- The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and radiation treatment, including proton therapy. The bra can also be used for breast support during other radiologic procedures such as CT, MRI and diagnostic X-rays. The bra, customizable for a wide variety of body types, is made of lightweight, advanced materials providing enhanced support ideal for positioning the breast and ensuring patient comfort without irritation or sensitization. FDA UDI
Identifiers
- Catalog Number
- CRTBRA01 FDA UDI
- Primary DI / UDI-DI
- 00860011280101 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600112801CRTBRANS EUDAMED
- Direct Marketing DI
- 00860011280101 EUDAMED
- 510(k) Number
- K121284 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Radiological breast positioner, wearable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Italy 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Chabner XRT by Chabner Xrt, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08600112801CRTBRANS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Chabner XRT, LLC
- EUDAMED SRN
- US-MF-000039131
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 5cd78fa7-aa2e-4028-a7b6-bc010195dfc4 61 fields · synced Jun 1, 2026
- FDA UDI 2616ccdd-17e0-49f3-be59-a80e473e9e97 36 fields · synced May 30, 2026