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Found 6 results
510(k) Data Aggregation
K Number
K162508Device Name
KerraCel Ag Gelling Fiber Silver Dressing
Manufacturer
Exciton Technologies Inc.
Date Cleared
2017-02-13
(158 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Exciton Technologies Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, KerraCel® Ag may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.
Device Description
KerraCel® Ag is a soft, sterile, nonwoven dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/ cm (1.7 wt/wt%)). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against gram positive and negative bacteria. KerraCel® Ag absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. KerraCel® Ag meets endotoxin limit specifications.
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K Number
K133775Device Name
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
Manufacturer
EXCITON TECHNOLOGIES INC.
Date Cleared
2014-03-26
(104 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EXCITON TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The exsalt® SD7 Wound Dressing with Adhesive Backing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt® SD7 Wound Dressing with Adhesive Backing provides an antibacterial barrier that inhibits bacterial growth in the dressing pad for up to 7 days.
Device Description
Exciton Technologies Inc. has developed the exSALT® technology, a proprietary chemical process, which deposits oxidized silver species onto a substrate; a non-woven polyester with a gray Delnet® HDPE mesh layer thermally laminated to one side (wound contact layer). The pad is backed with a clear polyurethane film with acrylate adhesive to hold the dressing in the exsalt® SD7 Wound Dressing with Adhesive Backing inhibits bacterial growth in the dressing pad. The concentration of the silver and oxidized silver species on the dressing pad is 0.4 mg/cm² (1.8%w/w). The exsalt® SD7 Wound Dressing with Adhesive Backing has been shown to be effective in vitro against Staphylococcus aureus. Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days.
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K Number
K113564Device Name
EXSALT T7 WOUND DRESSING
Manufacturer
EXCITON TECHNOLOGIES INC.
Date Cleared
2011-12-15
(13 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EXCITON TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The exsalt™ T7 Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt™ T7 Wound Dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing for up to 7 days.
Device Description
Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven polyester with gray Delnet® HDPE mesh layers thermally bonded on both sides. Silver in the exsalt™ T7 Wound Dressing inhibits bacterial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (4.5% w/w). The exsalt™ T7 Wound Dressing is known to be effective in vitro against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days. The exsalt™ T7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of polyester which are all silver-coated. The skin-contacting materials in both the exsalt™ T7 Wound Dressing and the predicate are the same. The exsalt™ T7 Wound Dressing is sterilized by gamma irradiation.
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K Number
K103067Device Name
EXSALT SD7 WOUND DRESSING
Manufacturer
EXCITON TECHNOLOGIES INC.
Date Cleared
2011-05-20
(214 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EXCITON TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The exsalt™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
Device Description
Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven needled polyester coated with gray Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (2.5% w/w). The exsalt™ SD7 Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis when they are in direct contact with the dressing. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonos aeruginosa and Staphylococcus aureus.
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K Number
K100580Device Name
EXSALT WOUND DRESSING
Manufacturer
EXCITON TECHNOLOGIES INC.
Date Cleared
2010-10-12
(224 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EXCITON TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The exsalt™ Wound Dressing is indicated for first aid to help minor cuts, scrapes, abrasion, lacerations and scalds.
Device Description
The exsalt™ Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. Exciton Technologies Inc. has developed exsalt™ technology; a proprietary chemical process, which deposits oxidized silver species onto the non-woven polvester coated with Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressit™ Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis.
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K Number
K083870Device Name
EXSALT SD7 WOUND DRESSING
Manufacturer
EXCITON TECHNOLOGIES INC.
Date Cleared
2009-07-30
(213 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EXCITON TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The exSALT ™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
Device Description
The exSALT™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. The dressing is available in various sizes and can be cut to size. Silver in the exSALT™ SD7 Wound Dressing kills bacteria which are in direct contact with the dressing.
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