AccessGUDID - DEVICE: SagiNova® Ir 25 channels, for Ir-192 only (04065983000030)

GUDID

Device Identifier (DI) Information

Brand Name: SagiNova® Ir 25 channels, for Ir-192 only
Version or Model: 06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1321-0202
Company Name: BEBIG Medical GmbH

Primary DI Number: 04065983000030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343363100 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAQ	System, Applicator, Radionuclide, Remote-Controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142986	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64f5dab0-2a18-4fe2-a00e-11643801373f
Public Version Date: February 01, 2024
Public Version Number: 1
DI Record Publish Date: January 24, 2024