Organization name

Elixir Medical Corporation

SRN

US-MF-000013041

Manufacturer status

Active

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

• Consult instructions for use

  Contraindications and Warnings are described in the product IFU.

• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date

Primary placement in Austria; available across 30 countries total.

Trade name

LithiX Hertz Contact Intravascular Lithotripsy Catheter

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.

00817508014978

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.

081750801LithiXY7

Reference / catalog number

DAR1514

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 III

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

• 14 MU50
• 1.5mm

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

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

• C01040199CARDIAC ANGIOGRAPHY DEVICES - OTHER

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.