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Irrisept Overview

Irrisept is jet lavage containing low concentration Chlorhexidine Gluconate (CHG) 0.05% in sterile water for irrigation. CHG acts as a preservative to help inhibit microbial growth in the solution.

The mechanical action of the Irrisept system removes particulate and debris. The unique bottle design allows users to control the delivery pressure of the solution through manual bottle compression. Grasping the bottle firmly, the user can control the direction and pressure needed to help remove particulate and debris.

Irrisept has successfully completed testing for cytotoxicity, skin irritation and sensitization/immune allergic response.

 

The Irrisept System

  • Irrisept is FDA-cleared (K080779), Class II Medical Device and an unclassfied combination product
  • Contents are wrapped in two sequential CSR wraps and sealed in a TYVEK® pouch, Model # ISEPT-450-USA

 

Irrisept contents include:

  • (1) Irrisept (450mL bottle containing 0.05% CHG in sterile water, USP (99.95%))
  • (1) Irriprobe applicator

 

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