Mechanical Front Pointer

GUDID B365113600

Elekta Compatible, direct mount

Aktina Corp.

Accelerator system quality assurance device

• Primary Device ID: B365113600
• NIH Device Record Key: a2a52249-0176-4d4b-b746-8a7acb72fb6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mechanical Front Pointer
• Version Model Number: 11-360
• 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	B365113600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990997

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 [Mechanical Front Pointer]

• B365531040: Siemens compatible
• B365113600: Elekta Compatible, direct mount