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510(k) Data Aggregation
K Number
K080497Device Name
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
Manufacturer
DERMA SCIENCES CANADA, INC.
Date Cleared
2008-06-27
(126 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERMA SCIENCES CANADA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for:
- abrasions
- minor lacerations
- minor cuts
- minor scalds and burns
Under the supervision of a healthcare professional, Algicelle Ag (Calcium Algiante Dressing with Antimicrobial Silver) dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wound such as:
- diabetic foot ulcer
- leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology
- pressure ulcers/sores (partial and full thickness)
- donor sites, and traumatic and surgical wounds.
Device Description
Calcium Alginate Dressing with Antimicrobial Silver is a primary wound dressing made of Calcium Alginate containing 1.4% Silver. In the presence of wound exudate, the sodium ions from the exudates take the place of the silver ions, releasing the silver ions. As wound exudate is absorbed, the alginate forms a gel, which assist in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions released in the presence of wound fluid protect the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The Sciences Derma Calcium Alginate Dressing with Antimicrobial Silver are sterile, single-use wound care dressings for use in moist wound management. This dressing is offered in several sizes including the following: 2"X2". 4.25"X4.25",4"X5",4"X8",8"X12".
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K Number
K053095Device Name
HONEY ALGINATE DRESSING
Manufacturer
DERMA SCIENCES CANADA, INC.
Date Cleared
2007-07-12
(616 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERMA SCIENCES CANADA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, API-MED™ ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily exuding wounds such as:
- diabetic foot ulcers .
- leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
- pressure ulcers / sores (partial and full thickness) .
- 1st and 2nd degree partial thickness burns .
- donor sites, and traumatic and surgical wounds. .
Device Description
Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing
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K Number
K052536Device Name
ALGICELL AG
Manufacturer
DERMA SCIENCES CANADA, INC.
Date Cleared
2006-09-13
(363 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERMA SCIENCES CANADA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, Algicell® Ag dressing is an effective barner to bacterial penetration in moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers/sores (partial and full thickness), donor sites, and traumatic and surgical wounds.
Device Description
Calcium Alginate Dressing with Antimicrobial Silver
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