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510(k) Data Aggregation
K Number
K073547Device Name
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL
Manufacturer
ANACAPA TECHNOLOGIES, INC.
Date Cleared
2008-04-23
(127 days)
Product Code
FRO, FOH
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ANACAPA TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: Anasept™ Antimicrobial Skin and Wound Gel is intended for OTC use for management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin. of being as a long and the Antimicrobial Skin and Wound Gel is intended to be used under the supervision of a healthcare professional in the management of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
OTC: Anasept™ Antimicrobial Skin and Wound Cleanser is intended for OTC use for mechanical cleansing of dirt and debris form skin abrasions, minor irritations, cuts, exit sites and intact skin.
Professional Use: Anasept™ Antimicrobial Skin and Wound Cleanser is intended for professional use for cleansing and removal of foreign material including micro-organisms and debris from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
Device Description
Anasept™ Antimicrobial Skin and Wound Gel is a clear, amorphous, isotonic hydrogel wound I thatept - - Intimerooms in a moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering antimicrobial sodium hypochlorite. This antimicrobial agent inhibits the growth of microorganisms. Anasept™ Antimicrobial Skin and Wound Gel will be supplied in collapsible blind ended, heat-sealed, coextruded tubes fitted with a "flip top" dispenser closure.
Anasept™ Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the mechanical removal of the debris and foreign material from the application site. Dirt, debris and foreign materials are mechanically removed by the action of the fluid (Wound Cleanser) moving across the wound bed or application site. The device also contains an antimicrobial agent that inhibits the growth of microorganisms. Anasept™ Antimicrobial Skin and Wound Cleanser will be supplied in High Density Polyethylene bottles in various packaging configuration: 15 oz in HDPE bottle with dispensing caps and 8, & 12 oz with Trigger sprayer and 8 oz with Finger pump sprayer.
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K Number
K062212Device Name
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
Manufacturer
ANACAPA TECHNOLOGIES, INC.
Date Cleared
2006-11-21
(112 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ANACAPA TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver Shield™ Antimicrobial Skin and Wound Gel is intended for OTC use for Abrasions and lacerations and under the supervision of a health care professional in the management of Stage 1-1V Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Grafted and donor sites,
Device Description
Silver Shield Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel wound dressing that helps maintain a moist wound environment that is conducive to healing, by either absorbing the wound exudates or donating the moisture while delivering antimicrobial silver. The gel matrix of the Silver Shield™ Antimicrobial Skin and Wound Gel is composed of a silver complex and an inert viscosity-modifying agent that imparts viscous hydrogel properties. Silver Shield™ Antimicrobial Skin and Wound Gel will be supplied in collapsible blind ended, heatsealed, co-extruded tubes fitted with a "flip top" dispenser closure. This reusable tube will be placed in a chipboard dispenser box with a package insert.
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