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510(k) Data Aggregation
K Number
K091863Device Name
AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS
Manufacturer
AUBREY, INC.
Date Cleared
2010-01-21
(212 days)
Product Code
FRO, KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AUBREY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AWBAT-S Plus: is intended for clean Superficial burn wounds.
AWBAT-D Plus: are intended for Donor sites after hemostasis has been established.
AWBAT-M Plus: are intended to be used as a protective covering for Meshed autografts.
Device Description
A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT Plus is composed of a single or multiple filesned knitted nylon fabric, bonded to a thin porous silicone membrane (enproximately 0.01 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen. peptides, chondroitin-4-sulfate, chondroitin-6-sulfate, Immuno-10 (Aloe polysiaconarides), vitamin C, vitamin E, and polysorbate 20.
AWBAT Plus is manufactured in 12"x12" sheets that are cut to sizes of 6"x6", 6"x12" and 12"x12" and ink stamped AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus accordingly.
AWBAT-S Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S Plus pore is 0.0036 square inch each.
AWBAT-D Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D Plus pore is 0.0073 square inch each.
AWBAT-M Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M Plus pore is 0.0070 square inch each.
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K Number
K082869Device Name
AWBAT-S, AWBAT-D, AWBAT-M
Manufacturer
AUBREY, INC.
Date Cleared
2009-02-06
(130 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AUBREY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AWBAT-S is intended for clean Superfical burn wounds.
AWBAT-D is intended for Donor sites after hemostasis has been established.
AWBAT-M is to be used as protective covering for Meshed autografts.
Device Description
A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT is composed of a single or multiple filament knitted nylon fabric, bonded to a thin porous silicone membrane (approx 0.001 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides.
AWBAT is manufactured in 12"x12" sheets that are cut to sizes of 3"x3", 6"x12" and 12"x12" and ink stamped "AWBAT-S," "AWBAT-D" or "AWBAT-M" accordingly.
AWBAT-S has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S pore is 0.0036 square inch each.
AWBAT-D has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D pore is 0.0073 square inch each.
AWBAT-M has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M pore is 0.0070 square inch each.
AWBAT-S is composed of a 15/2 denier multiple filament nylon knitted fabric, bonded to a thin porous silicone membrane. The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides (xenogenic component).
AWBAT-D has the same composition as AWBAT-S, except it is more porous to enable the clinician to evacuate a clot through the membrane into an outer sterile wrap.
AWBAT-M has the same composition as AWBAT-D, except the 12/1 denier nylon fabric is monofilament (thinner & less adherent).
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