1374-0600

Organization name

BEBIG Medical GmbH

SRN

DE-MF-000012644

Manufacturer status

Active

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

• CW999

  Contra-indication: The SagiPlan® Treatment Planning System is software program that provides HDR brachytherapy dose calculations for HDR remote afterloading brachytherapy treatment, therefore, the contraindications for this device include: • Cannot be used for low dose rate or pulse dose rate brachytherapy treatment planning • Can only be used with BEBIG SagiNova® and MultiSource HDR remote afterloader, applicators and accessories. It cannot be used with other HDR remote afterloaders. • Cannot be used for external beam treatment planning Contraindications for the clinical use of HDR brachytherapy treatment include: • Risk of radiation injury to critical organs • Very large tumors where the prescribed dose cannot be achieved • Presence of ataxia telangiectasia • Distant metastases (not applicable for palliative treatments, e.g., HDR brachytherapy of bronchial or oesophageal late-stage tumours) • Risk of bleeding (from use of anticoagulant therapy) • Unacceptable operative risks or medically unsuitable for anaesthesia (not applicable for HDR brachytherapy where local anaesthesia is sufficient or where no surgical intervention is necessary, e.g., HDR brachytherapy of the skin)
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 3 countries total.

Trade name

not provided

UDI-DI code

04065983000016

Basic UDI-DI

40659830002BC3

Reference / catalog number

1374-0600

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.

• Z11010392BRACHYTHERAPY RADIATION SYSTEMS - MEDICAL DEVICE SOFTWARE

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