AccuBoost PM-PA-PA

GUDID 00850306007544

Planmed Sophie - Paddle Assembly

ADVANCED RADIATION THERAPY, LLC

General-purpose brachytherapy system applicator, manual

• Primary Device ID: 00850306007544
• NIH Device Record Key: fb16d5ce-ae10-43e8-a943-39649ffbc39d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuBoost
• Version Model Number: 450123-02
• Catalog Number: PM-PA-PA
• Company DUNS: 193415051
• Company Name: ADVANCED RADIATION THERAPY, LLC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: (978)649-0007
• Email: info@accuboost.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850306007544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863890

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-12-03

On-Brand Devices [AccuBoost]

• 00850306007599: Planmed - DV Low Profile Magnification Stand
• 00850306007582: GE - DV Low Profile Magnification Stand
• 00850306007575: DM Magnification Stand Assembly
• 00850306007568: DM Positioning Tray
• 00850306007551: Digital Mammo - Paddle Assembly
• 00850306007544: Planmed Sophie - Paddle Assembly
• 00850306007537: GE - Paddle Assembly
• 00850306007520: DV Low Profile Bottom Positioning Tray
• 00850306007513: Positioning Accessory - Top