Organization name

Biosensors Interventional Technologies Pte Ltd

SRN

SG-MF-000015765

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.
• CW010

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

  The contraindications in the Instructions for Use (IFU) of the Lithonic Catheter also apply to the use of the Lithonic Generator. The Lithonic Generator, when used in conjunction with the Lithonic Catheter, has the following contraindications: • Patients with known sensitivity to contrast agents that cannot be treated prophylactically prior to the use of the coronary IVL system. • Pretreatment and dilatation of coronary stent • Pretreatment and dilatation of lesions in carotid and cerebrovascular arteries.
• CW999

  General warnings: Before operating the Lithonic Generator, users should read and understand the contents of the Lithonic Generator IFU. Before using the Lithonic Generator, please also read the IFU of the Lithonic Catheter (P/N: 12910-000).
• CW999

  General warnings: Ensure the Cable Connector M of the Lithonic Catheter is securely connected to the Connecting Cable F prior operating the Lithonic Generator. If the Lithonic Generator is not well connected, an error message will appear, and the system will not generate high-voltage pulses.
• CW999

  General warnings: The Lithonic Generator is to be used only with the accessories and cables provided. The use of third-party accessories and cables as replacement parts may damage the Lithonic Generator.
• CW999

  Explosion hazard: The Lithonic Generator and Lithonic Catheter when used together as a system will generate sparks during use. Do not use this product in the presence of flammable gases.
• CW999

  General warnings: The Lithonic Generator is intended for use by trained medical practitioners in professional healthcare facilities (Also see Section 3- Intended Use Environment).
• CW999

  Fire hazard: The Lithonic Generator contains a rechargeable lithium-ion battery.
• CW999

  Fire hazard: Do not disassemble the console, expose it to high temperature, or incinerate the Lithonic Generator or the battery.
• CW999

  Fire hazard: Do not immerse any part of the Lithonic Generator in water or other fluids.
• CW999

  Fire hazard: Do not immerse the Connecting Cable F, foot pedal/hand-held trigger handle, AC mains cable, and power adapter with DC cable in water or other fluids.
• CW999

  Electric shock hazard: This Lithonic Generator outputs a 3000V high-voltage pulse. Operate it in accordance with the requirements of this IFU. Failure to do so may result in serious electric shock injuries.
• CW999

  Fire hazard: Avoid splashing fluids onto the Lithonic Generator as it may cause a malfunction of the Lithonic Generator.
• CW999

  Fire hazard: Do not use corrosives to clean the Lithonic Generator.
• CW999

  Fire hazard: The above Fire Hazard Warnings when not followed, may cause damage to the Lithonic Generator, Connecting Cable F and foot pedal/hand-held trigger handle, or possibly result in a fire.
• CW999

  Electric shock hazard: When used in conjunction with the Lithonic Catheter, please pay attention to the inflation pressure and ensure the balloon is not damaged. Failure to do so may cause serious electric shock injuries.

Primary placement in Netherlands; available across 28 countries total.

Trade name

Lithonic

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08885021690186

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

888502169CILGMQ

Reference / catalog number

CILG-0001

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Coronary Intravascular Lithotripsy (IVL) Generator

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 227 MU50
• 119 MU50
• 284 MU50

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12059099VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.