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TRAUMAGEL® 2.0 is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.

TRAUMAGEL® 2.0 hemostatic gel contains chitosan granules suspended within a sodium alginate gel. The hemostatic gel is delivered via a syringe applicator. The chitosan is not dissolved within the sodium alginate gel. Chitosan does not delocalize from the hemostatic gel during application.

• The hemostatic gel contains two polymers: sodium alginate and poly (N-acetyl-D-glucosamine, D-glucosamine) (chitosan). These polymers are combined with water to form the hemostatic gel.
• The gel is viscous, opaque, and tan in color. The polymer components of the gel are non-animal, naturally derived, and as a result, syringe contents may appear darker over time.
• The hemostatic gel is intended for external application on breached and/or compromised skin.
• The hemostatic gel is pre-filled inside a sterile syringe and capped.
• The capped syringe is pouched and then terminally sterilized with gamma irradiation to a Sterility Assurance Level (SAL) 10⁻⁶.
• The device is supplied as an individually pouched 30 mL hemostatic gel syringe.

TRAUMAGEL® 2.0 hemostatic gel is labeled for single-use-only. TRAUMAGEL® 2.0 is not intended to remain in contact with a patient for more than 24 hours following application. The hemostatic gel is not intended for surgical use, nor is it intended as a wound-closure device.

TRAUMAGEL® 2.0 hemostatic gel final product testing for batch release includes visual inspection, pyrogen testing, sterility testing, and rheology testing.

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