Search Results
Found 1 results
510(k) Data Aggregation
K Number
K053538Device Name
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
Manufacturer
CURAPHARM, INC.
Date Cleared
2006-10-10
(294 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CURAPHARM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of 1st and 2nd degree burns, minor cuts and abrasions. Under the care of a healthcare professional the Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of diabetic ulcers, foot ulcers, 1st and 2nd degree burns, pressure ulcers (stages I-IV), cuts and abrasions.
Device Description
There are 2 components of the device. Phytacare® Alginate Hydrogel and the airless pump container. Phytacare® Alginate Hydrogel Wound Dressing contains sodium alginate, whose primary function is to absorb excess wound exudate, providing a moist wound environment to encourage natural healing. Phytacare Alginate hydrogel also contains moisturizers, thickeners and stabilizers, preservatives, and a fragrance. The Phytacare Alginate Hydrogel is packaged in 30 or 50 ml polypropylene airless pump containers.
Ask a Question
Page 1 of 1