Ingot

GUDID B525FI020

Octostop Inc

X-ray/radiation therapy beam filter, wedge X-ray/radiation therapy beam filter, wedge

• Primary Device ID: B525FI020
• NIH Device Record Key: e13381f5-802a-45d0-88f8-6c3b632fd18b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingot
• Version Model Number: FI-02
• Company DUNS: 240536946
• Company Name: Octostop Inc
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B525FI020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910757

FDA Product Code

• KPR: System, x-ray, stationary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-31

Devices Manufactured by Octostop Inc

• B525BO020 - Standard Board: 2019-03-11
• B525BO030 - Large Board: 2019-03-11
• B525CO010 - Large U Head Cushions: 2019-03-11
• B525CO020 - Small U Head Cushions: 2019-03-11
• B525CO030 - L Head and Arm Cushions: 2019-03-11
• B525OC010 - Octogones: 2019-03-11
• B525OC020 - Vertical Support: 2019-03-11
• B525PA030 - Octopaque no Accessories: 2019-03-11