Chabner XRT CRTBRA13

GUDID 00860011294924

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.

Chabner XRT, LLC

Radiological breast positioner, wearable

• Primary Device ID: 00860011294924
• NIH Device Record Key: e95b3b6d-d004-42ce-8ca4-7730334d9326
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chabner XRT
• Version Model Number: CRTBRA13
• Catalog Number: CRTBRA13
• Company DUNS: 119156147
• Company Name: Chabner XRT, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011294924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121284

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [Chabner XRT]

• 00860011294924: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011294917: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011294900: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280194: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280187: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280170: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280163: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280156: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280149: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280132: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280125: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280118: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860011280101: The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and ra
• 00860012102389: The Chabner XRT Bra Shoulder Extender "the extender" can only be used with the Chabner XRT Radia
• 00860012102372: The Chabner XRT Bra Extender "the extender" can only be used with the Chabner XRT Radiation Bra