Electron Beam Shaping Full System, Siemens 95 cm,

GUDID B365524850

Aktina Corp.

Radiation therapy beam block production plate Radiation therapy beam block production plate

• Primary Device ID: B365524850
• NIH Device Record Key: 5b67828b-2460-48d0-9ca9-73da0a34a38f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electron Beam Shaping Full System, Siemens 95 cm,
• Version Model Number: 52-485
• Company DUNS: 787178920
• Company Name: Aktina Corp.
• 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: true
• Expiration Date: false
• 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	B365524850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973953

FDA Product Code

• IXI: Block, Beam-Shaping, Radiation Therapy

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: 2016-09-24

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