1321-0201

Organization name

BEBIG Medical GmbH

SRN

DE-MF-000012644

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW999

  Contra-indication: For the Afterloading systems and accessories, Transfer Tubes and Connectors/Couplings: The manufacturer of the Afterloading systems and accessories and Transfer Tubes and Connectors/Couplings is not aware of any specific contraindications. The indication of when the use of brachytherapy is appropriate for a patient is solely subject to the respective specialist and his professional expertise and assessment. Identification of contraindications for HDR brachytherapy is not readily available in guidelines or publications since it is dependent on the physician's evaluation of the patient, and it is not connected to general clinical parameters. Several contraindications to HDR brachytherapy of prostate cancer are discussed in the document "The evolution of brachytherapy for prostate cancer" : •Ataxia telangiectasia •Pre-existing rectal fistula •Unacceptable operative risks or medicallyunsuitable for anesthesia •Distant metastases These contraindications do not necessarily apply to other HDR brachytherapy applications, for example, intraluminal HDR Brachytherapy, in which metastases are not contra-indicated (palliative care). Instead, the following contraindications are suggested : •Patients that have a medical contraindicationfor radical surgery •Risk of radiation injury to critical organs •Very large tumors where the prescribed dosecannot be achieved •Tracheal or bronchial involvement •Cervical esophagus location •Stenosis that cannot be bypassed Some contraindications to radical treatment using HDR Gynecologic Brachytherapy are given in an ABS task group proposal : •Prior pelvic radiotherapy with brachytherapy •Life expectancy < 6 months

Primary placement in Spain; available across 2 countries total.

Trade name

not provided

UDI-DI code

04065983000023

Basic UDI-DI

40659830001BBY

Reference / catalog number

1321-0201

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11010301BRACHYTHERAPY RADIATION SYSTEMS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification