DuraSheath Introducer Sheath System

Trade name

DuraSheath Introducer Sheath System

UDI-DI code

04251244503086

Basic UDI-DI

4251244500000013C

Reference / catalog number

FG-05045-F

Issuing entity

GS1

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the human vasculature, including but not limited to femoral access.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 45 MU10
• 1.92 MU50
• 5 MU170
• Straight

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

• C0502CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

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

• CW999

  Sterilize using ethylene oxide
• CW009

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

  EUDAMED did not publish a description for this code.
• CW011

  See instructions for use before use
• CW001

  EUDAMED did not publish a description for this code.