US FDA 510(k) Surface Use Market Clearance
Emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.
BloodSTOP® iX Trauma Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic wounds.
Topical control of bleeding from minor cuts and abrasions of the skin surface
External, short-term use hemostatic gauze for the control of bleeding from lacerations, cuts, abrasions, and venipuncture for the general population and for those on anticoagulant medications.
Internal use, wholly absorbable, for the control of bleeding during and after surgery, for the general population and for those on anticogulant medications. (Design Certificate)
View CE Class III Internal Use Instruction Sheet:
ISO 13485:2003 Certification
International Quality System Standard for Medical Device Manufacturing