AccessGUDID - DEVICE: Chabner XRT (00860012102372)

GUDID

Device Identifier (DI) Information

Brand Name: Chabner XRT
Version or Model: CRTEXT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CRTEXT
Company Name: Chabner XRT, LLC

Primary DI Number: 00860012102372
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119156147 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121284	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef16b544-306a-4624-8907-be74fad75336
Public Version Date: July 08, 2024
Public Version Number: 1
DI Record Publish Date: June 28, 2024