GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-007

GUDID 10850002615422

Skew 100-50-16M

XCISION MEDICAL SYSTEMS, LLC

Stereotactic radiotherapy breast positioning system pad

• Primary Device ID: 10850002615422
• NIH Device Record Key: a6122b2b-4618-4bbd-b7c0-15df7ab07ee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaPod™ Breast Immobilization and Localization System
• Version Model Number: Bolus
• Catalog Number: XMSGP030A10.08-007
• Company DUNS: 788286941
• Company Name: XCISION MEDICAL SYSTEMS, LLC
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-924-7466
• Email: service@xcision.com
• Phone: 1-855-924-7466
• Email: service@xcision.com

Device Dimensions

• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002615425 [Unit of Use]
GS1	10850002615422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180571

FDA Product Code

• IWB: System, Radiation Therapy, Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-22

On-Brand Devices [GammaPod™ Breast Immobilization and Localization System ]

• 00850002615074: Small
• 00850002615067: Medium
• 00850002615050: Large
• 00850002615043: Suction Pump
• 10850002615453: Skew 120-60-30L
• 10850002615446: Skew 120-60-20L
• 10850002615439: Skew 100-50-23M
• 10850002615422: Skew 100-50-16M
• 10850002615415: Skew 80-40-17S
• 10850002615408: Elliptical 120-60-30L
• 10850002615392: Elliptical 120-60-20L
• 10850002615385: Elliptical 100-50-23M
• 10850002615378: Elliptical 100-50-16M
• 10850002615361: Elliptical 80-40-17S