Search Results

Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. Celox Rapid X-ray Gauze will be packaged in a tear-pouch for the pre-hospital market and a peel pouch for the hospital market and is available by prescription only. The subject device is a modification to the legally marketed predicate device Celox Rapid Gauze, with the inclusion of an x-ray detectable strip. Celox Rapid X-Ray Gauze achieves its principle intended action (hemostasis) whereby the chitosan - hemostatic granules laminated to the gauze absorb blood and water creating a gelling action physically sealing the bleed site. As the water is absorbed, blood components are also amalgamated, in combination with manual pressure to the wound forming a gel coagulum at the site of bleeding. The device may be left in place for up to 72 hours. An additional standard gauze may be used if required.

Bondiloxs Topical Haemostatic Granules is indicated for use as a temporary topical dressing for external bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate bleeding.

The product is a chitosan-based haemostatic agent presented in a granular form in a sealed pouch. It is applied directly to the source of bleeding in a topical wound and pressure applied for up to 3 minutes until hemostasis is achieved. Bondiloxs Topical Hemostatic Granules achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, Bondiloxs Topical Hemostatic Granules quickly forms a strong seal that completely covers the wound.

Under the supervision of a healthcare professional Bondiloxs Topical Hemostatic Dressing is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate to severe bleeding.

Bondiloxs Topical Hemostatic Dressing is a sterile non-woven dressing comprising of chitosan fibres which aids the gelling and absorbency potential of the dressing. Bondiloxs Topical Hemostatic Dressing achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the Bondiloxs Topical Hemostatic Dressing directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding. The dressing promotes localized clotting formation to help stop bleeding. The Bondiloxs Topical Hemostatic Dressing is packed in a foil/foil pouch. The pouch provide an integral barrier that maintains dressing sterility post irradiation vet allows easy opening and aseptic dressing removal by the end user. The Bondiloxs Topical Hemostatic Dressing is available in various sizes ranging up to a maximum of 15cm x 15cm and is available in a flat dressing or z-folded for fast and intuitive application.

Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as: A hydrophilic foam patch that is used to absorb exudates and to cover the peri-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.

The Medtrade Product Ltd CHG Antibacterial Foam Patch consists of a hydrophilic Polyurethane absorbent foam with chlorhexidine gluconate (CHG) and a thin Polyurethane backing. The foam material absorbs up to eight times its own weight in fluid. The CHG present in the dressing inhibits or kills microorganisms on the surface of the dressing.

Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding. CELOX Gauze PRO (OTC) is indicated for use as a temporary topical dressing for minor cuts, minor abrasions, minor lacerations and minor burns.

CELOX Gauze PRO is identical to CELOX Hemostatic Granules on Sheet (510(k) # K080097) in product composition (raw materials), manufacturing processes and product performance. The device consists of a chitosan Haemostatic granules (CELOX PRO 510(k) # K093593) adhered onto a base fabric (non-woven gauze) using a hot melt adhesive. CELOX Gauze PRO achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the CELOX Gauze PRO directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding and reduce the risk of re-bleeding. In addition because CELOX Gauze PRO absorbs water from blood, platelets are concentrated, resulting in activation of platelets to help stop bleeding and reduce the risk of re-bleeding CELOX Gauze PRO is an effective solution that reduces time to haemostasis, even for patients on anticoagulants such as warfarin and heparin. The CELOX Gauze Pro is packed in a three layer laminate pouch of polyester, aluminium and LDPE. The pouch provide an integral barrier that maintains dressing sterility post irradiation yet allows easy opening and aseptic dressing removal by the end user. The CELOX Gauze PRO is available in various sizes ranging from 1" x 1" to 3″ x 10ft.

CELOX Rapid Gauze (Rx) is indicated for temporary external use to control moderate to severe bleeding. CELOX Rapid Gauze (OTC) is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Components – CELOX Rapid is composed of chitosan Mechanism of Action - CELOX Gauze achieves its principle intended action (hemostasis) by acting as a delivery system for the Celox Granules creating a physical barrier or seal to stop the flow of blood. When in contact with a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, the CLO. C Granules heat bonded on to the CELOX Rapid quickly form a strong seai that completely covers the wound.

CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding. CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.

CELOX Antibacterial Trauma Gauze (Silver containing Antibacterial Dressing) is a soft, sterile, non-woven gauze dressing. This dressing is composed of Chitosan, Chitosan derivatives and structural woven gauze materials with the addition of Ionic Silver. The silver ions present in the dressing help to inhibit bacterial growth in the dressing. The dressing absorbs high amounts of wound fluid and bacteria, conforms to the wound surface, maintains a moist and creates a soft, cohesive gel that aids in the removal of non-viable tissue (autolytic debridement). The moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the CELOX Antibacterial Gauze support the body's healing process.

CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French

CELOX Vascular is a kit that consists of a hemostatic pad and an optional adhesive bandage. The adhesive bandage is a 3M Tegaderm 4" x 4-3/4" bandage (reference K973036), or equivalent self adhesive security bandage. The hemostatic pad is a CELOX Hemostatic Granules on Sheet cleared in K080079 on July 9, 2008.

CELOX Topical Hemostatic Paste is indicated for the topical external temporary use to control moderate to sever bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters CELOX Topical Hemostatic Paste OTC is indicated for the topical external temporary use to control bleeding of lacerations, minor cuts and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied.

For OTC use MedTrade Product's CELOX Topical Hemostatic Paste OTC is indicated for the topical external temporary use to control bleeding of lacerations, minor cuts and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied. For professional use CELOX Topical Hemostatic Paste is indicated for the topical external temporary use to control moderate to sever bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters. The product is designed and packaged to be easily packed, carried and applied. It is well suited for low to moderate eviscerating wounds, to create hemolysis by coagulation. The CELOX Hemostatic Paste is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of the adjunctive manual compression. The CELOX Hemostatic Granules then cause hemostasis in which a natural blood clot can build and form a physical barrier to bleeding. MedTrade Products CELOX Topical Hemostatic Paste is provided in sterile tubes. Packaging will consist of between 1g to 50g of Paste. Biocompatibility testing summary has been provided. The device is packed in a tube and is provided sterilized by gamma irradiation. The product will be sterilised by gamma irradiation in accordance with the Sterilisation of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilisation, 30 Edition (ANSI/AAMI/ISO11137-1994) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991). Qualification will be based on Method 1 for dosimetric release with a sterility assurance level of 10 ° The product will receive a dose of 25 kGys to 35kGys.

CELOX Trauma Gauze is intended to be available Over The Counter for the following indication. Indications For OTC (Over The Counter) Use: CELOX Trauma Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions. CELOX Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.

CELOX Trauma Gauze Rx & OTC is identical in composition to Aquanova Super Absorbent Dressing Rx & OTC cleared in K070175 on July 25, 2007