Circular Small Field Cone Insert, Elekta, 7mm

GUDID B365503020700

Aktina Corp.

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• Primary Device ID: B365503020700
• NIH Device Record Key: 284ce3be-7bcd-4ea4-acf5-97c65d4496b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circular Small Field Cone Insert, Elekta, 7mm
• Version Model Number: 50-302-070
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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
GS1	00810110900042 [Secondary]
HIBCC	B365503020700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161984

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: 2016-10-04

Devices Manufactured by Aktina Corp.

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• 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