- uUS 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.
Consumer Use Topical control of bleeding from minor cuts and abrasions of the skin surface
- uCE Mark (EU) Surface Use Approval
External, short-term use hemostatic gauze for the control of bleeding from lacerations, cuts, abrasions, and venipuncture.
- uCE Mark (EU) Internal Use Approval (BloodSTOP® iX only)
Internal use, wholly absorbable, for the control of bleeding during and after surgery.