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510(k) Data Aggregation
K Number
K100693Device Name
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
Manufacturer
MEDTRADE PRODUCTS LIMITED
Date Cleared
2010-08-10
(152 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDTRADE PRODUCTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of partial and full thickness wounds 15 and 200 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.
Device Description
AQUANOVA Ag Super-Absorbent Dressing (Silver containing Antibacterial Dressing) is a soft, sterile, nonwoven pad or ribbon dressing is composed of Chitosan derivative materials with the addition of ionic silver ions. The ionic silver ions present in the dressing help to inhibit bacterial growth in the dressing. The dressing absorbs wound fluid and exudate and creates a soft, cohesive gel that intimately conforms to the wound bed and creates a moist wound healing environment conducive to wound healing and aids in the removal of non-viable tissue from the wound (autolytic debridement).
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K Number
K093593Device Name
CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO
Manufacturer
MEDTRADE PRODUCTS LIMITED
Date Cleared
2010-01-20
(62 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDTRADE PRODUCTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CELOX PRO 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.
CELOX PRO for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.
CELOX PRO for minor external bleeding from wounds and procedures (OTC) 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.
Device Description
Components - CELOX PRO is composed of chitosan, polymer, poly-N-acetyIglucosamine.
Mechanism of Action – CELOX Pro 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. CELOX PRO quickly forms a strong seal that completely covers the wound.
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