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510(k) Data Aggregation
K Number
K102478Device Name
OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
Manufacturer
SOUTHWEST TECHNOLOGIES, INC.
Date Cleared
2010-11-03
(65 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SOUTHWEST TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTC Manuka Honey Wound Dressing is indicated for minor cuts, minor abrasions, minor scalds and minor burns.
Device Description
OTC Elasto-Gel Manuka dressings are supplied as a gel (amorphous) a thickened viscosity honey or a gel sheet. OTC Elasto-Gel Manuka Honey sheet dressing is the same composition and identical to the Parent Product . The dressings will be supplied in many sizes, for example: 2x3, 4x4, 6x8, and possibly other additions sizes and shapes.
The amorphous gel is a mixture of a super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water. The crosslinked polyacrylamide polymer is insoluble in the wound fluid but has a relatively high capacity for absorption of the wound fluid, while releasing the glycerine, honey, and water into the wound fluid to establish a chemical equilibrium. The OTC Elasto-Gel Manuka Honey Amorphous gel dressing, is formulated to produce a high viscosity fluid mixture suitable for surface wounds cuts, scrapes and abrasions. The gel sheet is a moderately adhesive soft gel sheet that will protect the wound from shear, friction and pressure, suitable as a protective padding and cushioning device as well as functioning as a dressing. The OTC Elasto-Gel with Manuka Honey are limited to a slight change in indications and over the counter use.
The products will not dry out or become stuck to the wound. In most cases soon after application to the wound the pain level will be diminished . The provide a moist healing environment and will aid in the healing process.
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K Number
K083334Device Name
ELASTO-GEL MANUKA HONEY WOUND DRESSING
Manufacturer
SOUTHWEST TECHNOLOGIES, INC.
Date Cleared
2009-07-30
(260 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SOUTHWEST TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Elasto-gel Manuka Honey wound Dressings are indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers, (stages 1 -IV) venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds, and surgical wounds
Device Description
Elasto-Gel Manuka dressings are supplied as a gel(amorphous) or gel sheet. Elasto-Gel Manuka Honey sheet dressing is a sterile primary single use dressing comprised of aninsoluble polyacrylamide polymer matrix in the form of a continuous sheet with plasticizer of glycerine, honey, and water. The dressings will be supplied in many sizes, for example: 2x3", 4x4,6x8, and possibly other additional sizes and shapes The amorphous gel is a mixture of a super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water. The crosslinked polyacrylamide polymer is insoluble in the wound fluid but has a relatively high capacity for absorption of the wound fluid, while releasing the glycerine, honey, and water into the wound film to capit establish a chemical equilibrium. The Elasto-Gel Manica Honory and Match Houng Informulated to produce a high viscosity fluid mixture suitable for filling wound cavities. The gel sheet is a moderately adhesive soft gel sheet that will protect the wound from shear friction and pressure, suitable as a protective padding and cushioning device as well as functioning as a dressing.
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K Number
K030774Device Name
STIMULEN COLLAGEN
Manufacturer
SOUTHWEST TECHNOLOGIES, INC.
Date Cleared
2004-08-09
(517 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SOUTHWEST TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stimulen™ Collagen is indicated for prolonged use (24 hr to 30 days) in the management of wounds including:
- ·full and partial thickness wounds
- ·pressure ulcers (stages I-IV)
- •venous stasis ulcers
- ·diabetic ulcers
- ·partial thickness burns
- ·acute wounds
- ·abrasions
- •traumatic wounds healing by secondary intention
- •donor sites and other surface wounds
Device Description
Stimulen™ Collagen is a sterile primary single use dressing comprised of soluble modified bovine collagen base. The Stimulen™ collagen is soluble in the wound fluid and supplied as a powder or gel or sheet.
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