Beam Block Tray, Lexan, Slotted

GUDID B365116000

Aktina Corp.

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

• Primary Device ID: B365116000
• NIH Device Record Key: 2080d5ec-c3a9-4110-9f53-ea6e964445cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beam Block Tray, Lexan, Slotted
• Version Model Number: 11-600
• 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	B365116000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964840

FDA Product Code

• IYE: Accelerator, Linear, Medical

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

On-Brand Devices [Beam Block Tray, Lexan, Slotted]

• B365116000: 11-600
• B365115720: 11-572