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Found 43 results
510(k) Data Aggregation
K Number
K241916Device Name
TearRepair Liquid Skin Protectant
Manufacturer
OptMed, Inc.
Date Cleared
2024-09-27
(88 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.
Device Description
TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.
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K Number
K182733Device Name
Rochal Bioshield Silicone Film
Manufacturer
Rochal Industries, LLC
Date Cleared
2019-06-27
(272 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
Device Description
Rochal Bioshield Silicone Film is a polymeric solution which forms a protective, polymer film (silicone) when applied to skin. The product is biocompatible and non-stinging. The formed silicone film is colorless, transparent, water-proof barrier, which is breathable, possessing good oxygen and moisture vapor permeability.
Rochal® Bioshield Silicone Film will be supplied in a High-Density Polyethylene (HDPE), 28 mL bottles with pump spray cap.
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K Number
K171148Device Name
Aleo BME Liquid Bandage
Manufacturer
Aleo BME Inc.
Date Cleared
2018-01-12
(268 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Over the counter: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration in minor cuts, scrapes, burns, skin irritations and abrasions.
Prescription Use: Aleo BME Liquid Bandage is intended to cover and protect the skin from outside dirt and microbial penetration for minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
Device Description
ALEO liquid bandage is a tough elastic skin protectant for covering minor skin cuts, scrapes, abrasions and cracks. When applied, it rapidly forms water-proof, breathable and transparent protection that forms an effective barrier to prevent microbial penetration from the external environment while the polymeric film remains intact.
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K Number
K171735Device Name
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
Manufacturer
C.R. Bard, Inc.
Date Cleared
2017-08-08
(57 days)
Product Code
PTI
Regulation Number
880.5570Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.
The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.
Device Description
PowerLoc® MAX Power-Injectable Infusion Set
The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling.
The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set is offered with and without a Y-site.
SafeStep® Huber Needle Set
The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a needlestick prevention feature, designed for use with a vascular access infusion system. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.
Stabilization accessory
The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization accessory is then discarded per hospital protocol.
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K Number
K153571Device Name
Cavilon Advanced High Endurance Skin Protectant
Manufacturer
3M HEALTH CARE
Date Cleared
2016-08-23
(252 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cavilon™ Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon™ Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin.
Device Description
3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacylate is dispersed in a non-stinging solvent. The film is colorless and non-cytotoxic. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.
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K Number
K160684Device Name
Atteris No-Sting Skin Protectant
Manufacturer
ROCHAL INDUSTRIES LLC
Date Cleared
2016-07-26
(137 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a long-lasting waterproof barrier, protecting the skin from bodily wastes, fluids, add friction. It is intended as a primary barrier against irritation from body fluids.
Device Description
Atteris No Sting Skin Protectant is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. Atteris No Sting Skin Protectant shields intact or damaged skin from irritation caused by bodily fluids, wound drainage, adhesives, and friction. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.
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K Number
K131384Device Name
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
Manufacturer
KERICURE INC.
Date Cleared
2014-08-07
(450 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KeriCure™ Liquid Bandage and KeriCure Natural Seal™ Liquid Bandage: To help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
KeriCure™ Advanced Liquid Bandage: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
Device Description
The KeriCure™ Liquid Bandage family of products is comprised of a protective, elastic polymer film (proprietary polyacrylate polymer). As applied to the skin, the liquid bandage is slightly more viscous than water and sets within minutes to form a clear, breathable and completely transparent film. The Liquid Bandage is capable of adhering to both intact and compromised body tissue. The device is available with either a dropper or spray applicator.
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K Number
K133443Device Name
MARATHON NO STING LIQUID SKIN PROTECTANT
Manufacturer
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
Date Cleared
2014-07-10
(240 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Marathon No Sting Liquid Skin Protectant is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing).
Marathon No Sting Liquid Skin Protectant helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against irritation caused by adhesive products.
Device Description
Not Found
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K Number
K122634Device Name
IODOFOAM IODOPHOR FOAM DRESSING
Manufacturer
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC
Date Cleared
2013-03-12
(195 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.
Device Description
Iodofoam ® is a sterile, single use absorptive foam dressing consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, Iodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted
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K Number
K120059Device Name
LIQUID BANDAGE
Manufacturer
CHESSON LABORATORY ASSOCIATES, INC.
Date Cleared
2012-05-17
(129 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.
Device Description
This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.
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