Patient Restraining Belt

GUDID B365114350

Aktina Corp.

Radiological whole-body positioner

• Primary Device ID: B365114350
• NIH Device Record Key: 6a04466b-1586-4d19-9da3-d7fdf30253db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Restraining Belt
• Version Model Number: 11-435
• 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	B365114350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991546

FDA Product Code

• IYE: Accelerator, Linear, Medical

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

On-Brand Devices [Patient Restraining Belt]

• B365561100: 56-110
• B365114350: 11-435