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510(k) Data Aggregation

    K Number
    K133290
    Device Name
    COLLACARE DENTAL
    Manufacturer
    INNOCOLL PHARMACEUTICALS
    Date Cleared
    2014-05-01

    (188 days)

    Product Code
    KGN, CLA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collacare Dental is indicated for the management of oral wounds and sores, including: - denture sores - oral ulcers (non-infected or viral) - periodontal surgical wounds - suture sites - burns - surgical wounds and traumatic wounds
    Device Description
    Collacare Dental is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only. Sizes available include the following: Dental Sponges: 3.6cm x 1.8cm, 2.5cm x 2.5cm and 2.5cm x 5cm Dental Cone: Height-17mm Ø Top - 10mm Ø Bottom - 14mm
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    K Number
    K120339
    Device Name
    PROCOLL
    Manufacturer
    INNOCOLL PHARMACEUTICALS
    Date Cleared
    2012-06-21

    (139 days)

    Product Code
    KGN, CLA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Procoll may be used for the management of full and partial thickness wounds including: - Diabetic ulcers . - . Venous ulcers - Pressure ulcers . - Ulcers caused by mixed vascular etiologies - Abrasions . - . Traumatic wounds - 1st and 2nd degree burns . - Dehisced surgical wounds . - Exuding wounds .
    Device Description
    Procoll is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Procoll is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
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    K Number
    K103648
    Device Name
    COLLAGEN POWDER
    Manufacturer
    INNOCOLL PHARMACEUTICALS LTD
    Date Cleared
    2011-09-14

    (274 days)

    Product Code
    KGN, CLA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collagen Powder may be used for the management of wounds such as: - Diabetic ulcers - Venous ulcers - Pressure ulcers - Ulcers caused by mixed vascular etiologies - Full-thickness & partial thickness wounds - Abrasions - Traumatic wounds - 1st and 2nd degree burns - Dehisced surgical wounds - Exuding wounds
    Device Description
    Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.
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    K Number
    K110388
    Device Name
    COLLACARE DENTAL
    Manufacturer
    INNOCOLL PHARMACEUTICALS LTD
    Date Cleared
    2011-08-09

    (180 days)

    Product Code
    KGN, CLA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collacare Dental is indicated for the management of oral wounds and sores, including: - denture sores - oral ulcers (non-infected or viral) - periodontal surgical wounds - suture sites - burns - surgical wounds and traumatic wounds
    Device Description
    Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
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    K Number
    K100574
    Device Name
    COLLEXA
    Manufacturer
    INNOCOLL PHARMACEUTICALS
    Date Cleared
    2010-10-28

    (241 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collexa may be used for the management of wounds such as: - Diabetic ulcers - · Venous ulcers - . Pressure ulcers - Ulcers caused by mixed vascular etiologies . - Full-thickness & partial thickness wounds . - Abrasions . - Traumatic wounds . - 1st and 2nd degree burns . - Dehisced surgical wounds . - Exuding wounds .
    Device Description
    Collexa is a collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds as described in the intended use section of this 510(k) summary. The polyurethane foam is absorbent and acts as a reservoir for wound exudates. The product is supplied sterile for single use only.
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    K Number
    K092805
    Device Name
    COLLAGEN SPONGE
    Manufacturer
    INNOCOLL PHARMACEUTICALS
    Date Cleared
    2010-02-16

    (158 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collagen Sponge may be used for the management of wounds such as: - Pressure ulcers . - . Venous stasis ulcers - . Diabetic ulcers - First and second degree burns . - Partial and full thickness wounds . - Superficial injuries .
    Device Description
    Collagen Sponge is a collagen matrix sponge intended for topical use. The product is supplied sterile for single use only.
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    K Number
    K081782
    Device Name
    COLLIEVA
    Manufacturer
    INNOCOLL PHARMACEUTICALS
    Date Cleared
    2008-09-30

    (99 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collieva™ may be used for the management of wounds such as: - · Pressure ulcers - Venous stasis ulcers - · Diabetic ulcers - · First and second degree burns - · Partial and full thickness wounds - · Superficial injuries
    Device Description
    Collieva™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.
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    K Number
    K061746
    Device Name
    COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
    Manufacturer
    INNOCOLL PHARMACEUTICALS
    Date Cleared
    2006-10-02

    (103 days)

    Product Code
    KGN, KMF
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOCOLL PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollaGUARD may be used for the management of wounds such as: - Pressure ulcers . - . Venous stasis ulcers - . Diabetic ulcers - First and second degree burns . - Partial and full thickness wounds . - Superficial injuries .
    Device Description
    CollaGUARD™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.
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