Organization name

Meril Life Sciences Pvt. Ltd.

SRN

IN-MF-000008308

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged

Primary placement in Croatia; available across 13 countries total.

Trade name

Mozec™ PTA 0.035"

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.

18906029359237

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.

89042249OPTABDC0357M

Reference / catalog number

MO35080030B

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

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

Status

On the market

Quantity

1

Additional product description

Mozec™ PTA OTW 0.035” Balloon Dilatation Catheter consists of a Balloon (dilatation element) near the distal tip with radiopaque marker bands, which represent the approximate balloon working length at nominal pressure. The proximal end has a Y luer hub for balloon inflation. The catheter has a soft tip at the distal end. Dual lumens shaft which permit movement of guide wire and balloon inflation. The distal portion of the shaft has hydrophilic coating applied on it, in order to facilitate catheter advancing through the vascular district and the vessel stenosis. The compliance chart on the inner and outer label indicates how the balloon diameter increases with increasing pressure. The compliance data is based on in vitro testing of balloons at 37°C temperature.  Guide wire compatibility: 0.035”  0.035” OTW PTA Balloon Dilatation Catheter available with two usable length viz. 80 cm and 135 cm. The Mozec™ PTA OTW 0.035”Balloon Dilatation Catheter is available in different balloon sizes. Nominal balloon diameters and lengths are printed on the hub. Refer package label for information on catheter for usable length, Nominal and Rated burst pressure and Sheath compatibility.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 8 MU50
• 30 MU50

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

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

• C010402020101PTA BALLOON DILATATION CATHETERS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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