Search Results
Found 2 results
510(k) Data Aggregation
K Number
K081977Device Name
PROSIT WOUND TREATMENT DEVICE
Manufacturer
SILVERLEAF MEDICAL PRODUCTS, INC.
Date Cleared
2008-12-01
(143 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SILVERLEAF MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.
For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.
Device Description
Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polyester fabric is single ply and is made from multi-filament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design. In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.
Ask a Question
K Number
K060237Device Name
CMB ANTIMICROBIAL DRESSING
Manufacturer
SILVERLEAF MEDICAL PRODUCTS, INC.
Date Cleared
2006-06-15
(136 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SILVERLEAF MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.
Device Description
The CMB Antimicrobial dressing is a single layer dressing consisting of a woven adsorbent polyester containing elemental silver and zinc. In the presence of exudate, the dressing can be used with an appropriate secondary barrier to help maintain a moist wound healing environment.
Ask a Question
Page 1 of 1