Nova Surface Applicator

Basic Information

• Brand Name: Nova Surface Applicator
• Primary DI: 00860007402371
• Version / Model: N/A
• Catalog Number: ADPT-ONDEM-3DPRT-BRA
• Company Name: Adaptiiv Medical Technologies Inc
• Labeler DUNS: 203502513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-09
• Public Version: 1
• Public Version Date: 2024-12-17
• Public Version Status: New
• Public Device Record Key: 59d48110-526f-48cd-a122-29828369233c

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38435	General-purpose brachytherapy system applicator, manual	A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007402371	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241318	000