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Super Sheath™ Introducer Sheath

Indications, Safety and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Super Sheath Introducer Sheath

INDICATIONS

This device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

CONTRAINDICATIONS

None known.

PRECAUTION

This device is only to be used by a trained physician.

ADVERSE EVENTS

  • Air embolism
  • Infection
  • Intimal tear
  • Hemorrhage (hematoma or retroperitoneal bleed)
  • Perforation of the vessel wall
  • Thrombus formation, vessel occlusion
  • AV fistula
  • Emboli
  • Pseudoaneurysm

Super Sheath XL Large Diameter

INDICATIONS

This device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

CONTRAINDICATIONS

None known.

WARNING

NOTE: This product contains Di(2-ehylhexyl) phthalate (DEHP). Togo Medikit has conducted a Chemical Safety Assessment of DEHP in this device based on currently known acceptable exposure limits for sensitive populations (children and pregnant/nursing women), and has determined that the potential exposure is below the known acceptable exposure limits for the device when used in accordance with the indications and instructions for use.

PRECAUTION

This device is only to be used by a trained physician.

ADVERSE EVENTS

  • Air embolism
  • Infection
  • Intimal tear
  • Hemorrhage (hematoma or retroperitoneal bleed)
  • Perforation of the vessel wall
  • Thrombus formation
  • vessel occlusion
  • AV fistula
  • Emboli
  • Pseudoaneurysm

Super Sheath RO Introducer Sheath

INDICATIONS

This device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

CONTRAINDICATIONS

None known.

PRECAUTION

This device is only to be used by a trained physician.

ADVERSE EVENTS

  • Air embolism
  • Infection
  • Intimal tear
  • Hemorrhage (hematoma or retroperitoneal bleed)
  • Perforation of the vessel wall
  • Thrombus formation
  • vessel occlusion
  • AV fistula
  • Emboli
  • Pseudoaneurysm

 

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