FDA UDI
In Commercial Distribution
🇺🇸 United States
Chabner XRT
DI: 00860012102372
·
Model: CRTEXT
·
CHABNER XRT LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chabner XRT
- Primary DI
- 00860012102372
- Version / Model
- CRTEXT
- Catalog Number
- CRTEXT
- Company Name
- CHABNER XRT LLC
- Labeler DUNS
- 119156147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-28
- Public Version
- 2
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- ef16b544-306a-4624-8907-be74fad75336
Device Description
The Chabner XRT Bra Extender "the extender" can only be used with the Chabner XRT Radiation Bra "the bra" to extend the back of the bra for optimal fit and breast support during simulation, planning and radiation treatment, including proton therapy. The bra, with extender if needed, 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62979 | Radiological breast positioner, wearable | A garment designed to be worn by a female patient to support/position the breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is typically in the form of a brassiere. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012102372 | GS1 |
Customer Contacts
- Phone
- 9147138550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121284 | 000 |