EGIS Biliary Flared Fully Covered Stent

Organization name

VASNOVA INC.

SRN

KR-MF-000015781

Manufacturer status

Active

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

• CW010

  Contraindications for the EGIS Biliary Stents include, but may not be limited to: Patients with angina or coagulopathy or uncorrected bleeding disorders, Strictures that do not allow passage of a guidewire, Patients with large-volume ascites, Extensive hepatic metastases precluding a percutaneous transhepatic approach, Neonatal, pediatric and adolescent use, Benign strictures – except for removable configurations, Any use other than those specifically outlined under indications for use, Patients with contraindicated endoscopic procedure
• CW026

  The patients who have implanted this device may be scanned safely on a MRI Environment that satisfies as below: • Static magnetic Field of 1.5-Tesla and 3.0-Tesla • Maximum spatial gradient magnetic field of 3,000 gauss/cm • Maximum MR system reported, whole body averaged specific absorption rate(SAR) of 2 w/kg Additional description . Under the above defined scanning conditions, the maximum temperature rise is expected to be less than 2.8℃ when the EGIS Biliary stent was MRI performed for 15 minutes of scanning. From the non-clinical testing, the distorted image due to the medical device was extended up to 2.5 mm when it was scanned under T1 SE, GRE pulse sequence of 3.0-Tesla MRI.

Primary placement in Czechia; available across 7 countries total.

Trade name

EGIS Biliary Flared Fully Covered Stent

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.

08800038119383

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-08800038119383

Reference / catalog number

FFPC08050

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

MDD [Directive 93/42/EEC 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

• 8 MU50
• Delivery system diameter — 8 MU170
• 50 MU50
• Delivery system usable length — 50 MU10

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

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

• P0502BILIARY AND PANCREATIC PROSTHESES

• Class IIb medical devices in EUDAMED

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