Universal Leveling Plate System, Elekta Compatible

GUDID B365112690

Aktina Corp.

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

• Primary Device ID: B365112690
• NIH Device Record Key: 40ca1d56-9584-4455-8605-396487d44080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Leveling Plate System, Elekta Compatible
• Version Model Number: 11-269
• 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	B365112690 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-31
• Device Publish Date: 2021-05-21

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