Beam Block Tray, Acrylic, Solid, Set of 10

GUDID B365115511

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: B365115511
• NIH Device Record Key: 3aeac8b9-6d6d-4483-aae6-6f91980521d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beam Block Tray, Acrylic, Solid, Set of 10
• Version Model Number: 11-551
• Company DUNS: 787178920
• Company Name: Aktina Corp.
• Device Count: 10
• 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	B365115510 [Unit of Use]
HIBCC	B365115511 [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

Devices Manufactured by Aktina Corp.

• B36550366050 - Circular Small Field Cone Insert, Varian, 5mm: 2021-06-01
• B36550366060 - Circular Small Field Cone Insert, Varian, 6mm: 2021-06-01
• B36550366070 - Circular Small Field Cone Insert, Varian, 7mm: 2021-06-01
• B36550366080 - Circular Small Field Cone Insert, Varian, 8mm: 2021-06-01
• B36550366090 - Circular Small Field Cone Insert, Varian, 9mm: 2021-06-01
• B36550366100 - Circular Small Field Cone Insert, Varian, 10mm: 2021-06-01
• B36550366110 - Circular Small Field Cone Insert, Varian, 11mm: 2021-06-01
• B36550366120 - Circular Small Field Cone Insert, Varian, 12mm: 2021-06-01