Hand Grip

GUDID B365526340

Aktina Corp.

Indexed-immobilization patient positioning system

• Primary Device ID: B365526340
• NIH Device Record Key: ee87eb1d-f4fe-4bd9-af7a-f292932500eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hand Grip
• Version Model Number: 52-634
• 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	B365526340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991546

FDA Product Code

• JAI: Couch, Radiation Therapy, Powered

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 [Hand Grip]

• B365601400: 60-140
• B365526340: 52-634