High Energy Beam Block Set

GUDID B365112900

Aktina Corp.

Manual-aperture-control therapeutic x-ray system collimator, non-motorized Manual-aperture-control therapeutic x-ray system collimator, non-motorized

• Primary Device ID: B365112900
• NIH Device Record Key: 9b00a8d8-94bb-444c-8d1b-3e9169af4d31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High Energy Beam Block Set
• Version Model Number: 11-290
• 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	B365112900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974239

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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