SagiNova® 25 channels, for Co-60 and Ir-192 1321-0201

GUDID 04065983000023

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.

BEBIG Medical GmbH

Remote-afterloading brachytherapy system

• Primary Device ID: 04065983000023
• NIH Device Record Key: 189b9d52-3750-4b39-bd76-afdbeb3b2ec6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SagiNova® 25 channels, for Co-60 and Ir-192
• Version Model Number: 06
• Catalog Number: 1321-0201
• Company DUNS: 343363100
• Company Name: BEBIG Medical GmbH
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04065983000023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142986

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

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: 2024-02-01
• Device Publish Date: 2024-01-24

Devices Manufactured by BEBIG Medical GmbH

• 04065983002850 - Disposable steel needle, 17G, L=200mm: 2024-09-26 The Disposable Steel Needles are intended for interstitial brachytherapy applications.
• 04065983000986 - Transfer Tube, D=3mm, L=1000mm: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983000993 - Transfer Tube, D=3mm, L=1000mm, Green, Channel 1: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001006 - Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001013 - Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001020 - Transfer Tube, D=3mm, L=1000mm, T-connector: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001037 - Transfer Tube, D=3mm, L=1000mm, Green, Channel 1, T-connector: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).
• 04065983001044 - Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2, T-connector: 2024-05-06 The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).