SagiNova® Ir 25 channels, for Ir-192 only

Basic Information

• Brand Name: SagiNova® Ir 25 channels, for Ir-192 only
• Primary DI: 04065983000030
• Version / Model: 06
• Catalog Number: 1321-0202
• Company Name: BEBIG Medical GmbH
• Labeler DUNS: 343363100
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-24
• Public Version: 1
• Public Version Date: 2024-02-01
• Public Version Status: New
• Public Device Record Key: 64f5dab0-2a18-4fe2-a00e-11643801373f

Device Description

SagiNova® is a family of BEBIG Medical (and Eckert & Ziegler BEBIG) HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote-controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.

Device Characteristics

• Single Use: No
• 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
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	892.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38300	Remote-afterloading brachytherapy system	An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04065983000030	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142986	000