Mesh Insert Side Opening, Short Version

GUDID B365112180

Aktina Corp.

Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner

• Primary Device ID: B365112180
• NIH Device Record Key: e702fbdb-d6e2-4ab8-8e23-fe3b474c4c30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mesh Insert Side Opening, Short Version
• Version Model Number: 11-218
• 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	B365112180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993522

FDA Product Code

• JAI: Couch, Radiation Therapy, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-09-24

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• B36550366110 - Circular Small Field Cone Insert, Varian, 11mm: 2021-06-01
• B36550366120 - Circular Small Field Cone Insert, Varian, 12mm: 2021-06-01