Organization name

Lifetech Scientific (Shenzhen) Co., Ltd.

SRN

CN-MF-000001561

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

Primary placement in France; available across 32 countries total.

Trade name

Fustar

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.

06938370116875

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.

B-06938370116875

Reference / catalog number

SVA12F-700

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The FustarTM Steerable Introducer is designed to perform as a guiding sheath and/or introducer sheath, and the introducer is a single-use percutaneous accessory for deploying and retrieving devices in patients vessel. The introducer is available with a radiopaque band/tip incorporated within the sheath material to identify the location of the sheaths distal tip. The FustarTM Steerable Introducers low-profile design and atraumatic tip reduce the potential for trauma during transseptal punctures while facilitating passage of a wide variety of catheters and devices. By combining a low profile with high-tech capabilities, the FustarTM Steerable Introducer gives physicians greater control during the procedures. Curl options include type A (25.0 mm) and type B (50.0 mm). The usable length can be 550mm, 700mm, 800mm and 900mm. The introducer set is composed of steerable sheath, dilator, loader, haemostatic valve and delivery cable. The introducer allows a device to be advanced to the desired or hard-to-reach position and it facilitates delivery, deployment and retrieval of the interventional devices.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• P0780VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.