Mozec™ NC

Trade name

Mozec™ NC

18904224951492

B-18904224951492

Reference / catalog number

MNCD22538

GS1

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Mozec™ NC - Rx PTCA Balloon Dilatation catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon (dual-layer), a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. The balloon is folded to achieve a low profile. Radiopaque platinum/iridium marker(s) facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec™ NC balloon's working length. The outer lumen of the distal shaft is used for inflation and deflation of the balloon and the inner lumen provides guide wire (≤ 0.014") access for advancement of the catheter through the artery and across the lesion. The Rx port, located 25 cm proximal to the soft tip, provides an exit port for the guide wire. A hydrophilic coating covers the balloon and extends proximally from the balloon to the Rx port. The proximal shaft has a luer locking hub for balloon inflation/deflation. Two markers on the proximal shaft indicate the catheter position relative to the tip of a brachial (90 cm) or femoral (100 cm) guiding catheter. A protective sheath is placed over the balloon to prevent any inadvertent damage to the balloon before use and also to retain the balloon profile. A stylet is inserted in the inner lumen to prevent kinking or damage to the inner lumen. The protective sheath and the stylet are to be removed prior to use. Mozec™ NC is compatible with ≤0.014" (0.36mm) Guide wires and ≥ 5F (0.056"/1.42mm) Guiding catheters. The usable length of the Mozec™ NC is 142cm. The Mozec™ NC product range includes balloon diameters ranging from 2.00 mm to 5.00 mm and balloon lengths ranging from 8 mm to 38 mm.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 38 MU50
• 2.25 MU50

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

• C010401020101PTCA BALLOON DILATION CATHETERS

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

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

  EUDAMED did not publish a description for this code.