AccessGUDID - DEVICE: GammaPod™ Breast Immobilization and Localization System (10850002615378)

GUDID

Device Identifier (DI) Information

Brand Name: GammaPod™ Breast Immobilization and Localization System
Version or Model: Bolus
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XMSGP030A10.08-002
Company Name: XCISION MEDICAL SYSTEMS, LLC

Primary DI Number: 10850002615378
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 788286941 *Terms of Use

Device Description: Elliptical 100-50-16M

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
64185	Stereotactic radiotherapy breast positioning system pad	A cushion-like device designed to help facilitate reproducible positioning/immobilization of a female breast during stereotactic radiotherapy (SRT) imaging and treatment, by providing a bulking agent within a confined cup applied to the breast(s). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWB	System, Radiation Therapy, Radionuclide

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
Total Volume: 24 Milliliter

Device Record Status

Public Device Record Key: 3f914fe5-c54f-4715-ae8a-d4ae66b3e0e8
Public Version Date: September 01, 2025
Public Version Number: 3
DI Record Publish Date: March 22, 2019