GammaPod™ Breast Immobilization and Localization System

Basic Information

• Brand Name: GammaPod™ Breast Immobilization and Localization System
• Primary DI: 10850002615422
• Version / Model: Bolus
• Catalog Number: XMSGP030A10.08-007
• Company Name: XCISION MEDICAL SYSTEMS, LLC
• Labeler DUNS: 788286941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-03-22
• Public Version: 2
• Public Version Date: 2019-04-03
• Public Version Status: Update
• Public Device Record Key: a6122b2b-4618-4bbd-b7c0-15df7ab07ee4

Device Description

Skew 100-50-16M

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWB	System, Radiation Therapy, Radionuclide	Radiology	892.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850002615422	GS1
Unit of Use	00850002615425	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180571	000

Device Sizes

Type	Value	Unit	Text
Total Volume	35	Milliliter