ClearSheath

Trade name

ClearSheath

08906194164806

890619416NTISQ2

Reference / catalog number

NT/IS/FSS/0607

GS1

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

06F X 07cm . S Type Femoral Sheath with dilator

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 6 MU170

1 packaging level registered — each level carries its own UDI-DI.

• 08906194164806× 1 unitBase unit
  • 18906194164803× 5 units

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

• C0502CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

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

• •Prior to beginning Femoral artery access, an assessment such as the Allen’s test should be performed to assess the presence/adequacy of dual arterial circulation to the hand. •Do not use the Introducer sheath introducer in patients with an abnormal Allen’s test or insufficient dual arterial supply. •Do not advance the introducer and/or guide wire if resistance is met. •Do not attempt to use a guidewire/catheter or any other interventional medical device with a maximum diameter greater than specified on package label. • Do not reinsert the inner metal needle into the plastic cannula at any time. •Do not use device with a power injector. •Appropriate flushing protocols should be utilized to prevent thrombus formation during procedural use. •After flushing the side port, turn the stopcock to the off position to maintain the flush and prevent bleed-back when inserting into the vessel. • Avoid wiping the outer surface of the sheath introducer with dry gauze. •Ensure the dilator is securely snapped into place to prevent vessel damage. •Ensure the sheath surface is wet before insertion; do not use the sheath in a dry state. •During insertion, hold the assembly near the distal tip while passing it over the guide wire and into the vessel to prevent buckling. •Turn the stopcock handle to the off position, towards the sheath hub, to prevent unintended blood loss.

  OTHER