Nova Surface Applicator ADPT-ONDEM-3DPRT-BRA

GUDID 00860007402371

Nova Surface Applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of High Dose Rate (HDR) brachytherapy by providing a patient-specific fit and catheter trajectory design. The applicator is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, and radiation therapists. It is only intended to be utilized in radiation therapy, where a patient requires a total prescription dose on or near the skin surface. The device is made of methacrylic resin.

Adaptiiv Medical Technologies Inc

General-purpose brachytherapy system applicator, manual

• Primary Device ID: 00860007402371
• NIH Device Record Key: 59d48110-526f-48cd-a122-29828369233c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nova Surface Applicator
• Version Model Number: N/A
• Catalog Number: ADPT-ONDEM-3DPRT-BRA
• Company DUNS: 203502513
• Company Name: Adaptiiv Medical Technologies Inc
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007402371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241318

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2024-12-17
• Device Publish Date: 2024-12-09

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