DEVICE: Chabner XRT (00860012102372)

Device Identifier (DI) Information

Chabner XRT
CRTEXT
In Commercial Distribution
CRTEXT
Chabner XRT, LLC
00860012102372
GS1

1
119156147 *Terms of Use
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.
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, Linear, Medical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121284 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ef16b544-306a-4624-8907-be74fad75336
July 08, 2024
1
June 28, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
9147138550
inquiries@chabnerxrt.com
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