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510(k) Data Aggregation
K Number
K964398Device Name
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
Manufacturer
Date Cleared
1997-10-24
(354 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
POLYMEDICA INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SPYROFLEX Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Abrasions Blisters Burns (sun burns, carpet burns, friction burns, minor chemical and heat burns) Cuts Lacerations Poison Ivy Rash Scrapes
Device Description
SPYROFLEX® is a sterile, conformable, absorptive dressing. SPYROFLEX dressings consists of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while maintaining a protective moist healing environment. The wound contact surface of SPYROFLEX is a porous, non-toxic adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane acts as a reservoir for wound exudate. The outer layer performs as a barrier to bacteria, dirt, and liquids.
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K Number
K971045Device Name
BASIS FLEXIBLE TIP DIGITAL THERMOMETER
Manufacturer
Date Cleared
1997-05-02
(42 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
POLYMEDICA INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
Device Description
The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature".
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K Number
K964701Device Name
MITRAFLEX PIGMENTED WOUND DRESSING
Manufacturer
Date Cleared
1997-02-07
(74 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
POLYMEDICA INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MITRAFLEX Pigmented Wound Dressings are intended for use in the management of: Venous stasis ulcers, Diabetic ulcers, Pressure sores, Donor sites, Blisters, Incisions, Severe sunburn, Poison Ivy, Dermabrasions and other dermatologic procedures, Partial-thickness wounds, Superficial burns, Abrasions and lacerations, Full-thickness wounds, Skin tears, Dermal lesions, Minor chemical burns, Thermal burns, Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
Device Description
MITRAFLEX Pigmented Wound Dressings are sterile, absorptive dressings. MITRAFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. MITRAFLEX dressings are constructed of three layers, each specifically engineered to give MITRAFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing. The wound contact surface of MITRAFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. MITRAFLEX is impermeable to microorganisms and liquids.
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K Number
K963623Device Name
SPYROFLEX PIGMENTED WOUND DRESSING
Manufacturer
Date Cleared
1996-10-25
(44 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
POLYMEDICA INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SPYROFLEX Pigmented Wound Dressings are intended for use in the management of.
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Blisters
Incisions
Severe sunburn
Poison Ivy
Dermabrasions and other dermatologic procedures
Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
Partial-thickness wounds
Superficial burns
Abrasions and lacerations
Full-thickness wounds
Skin tears
Dermal lesions
Minor chemical burns
Thermal burns
Device Description
SPYROFLEX Pigmented Wound Dressings are sterile, absorptive dressings.
SPYROFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable.
SPYROFLEX dressings are constructed of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing.
The wound contact surface of SPYROFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. SPYROFLEX is impermeable to microorganisms and liquids.
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K Number
K962991Device Name
BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
Manufacturer
Date Cleared
1996-09-12
(42 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
POLYMEDICA INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
Device Description
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
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