AccessGUDID - DEVICE: Chabner XRT Radiation Bra (00841439111611)

GUDID

Device Identifier (DI) Information

Brand Name: Chabner XRT Radiation Bra
Version or Model: CRTBRA04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CRTBRA04
Company Name: MEDTEC, INC.

Primary DI Number: 00841439111611
Issuing Agency: GS1
Commercial Distribution End Date: March 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: Chabner XRT Radiation Bra

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:	No
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
LNH	System, nuclear magnetic resonance imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Circumference: 31.5 Inch

Device Record Status

Public Device Record Key: bb48eeb1-07df-4d4a-a8bf-b0d51af38fbb
Public Version Date: March 11, 2024
Public Version Number: 10
DI Record Publish Date: November 30, 2017