Label: KERAMATRIX- amino acids, hair keratin not applicable

  • NHRIC Code(s): 71474-303-01, 71474-303-50, 71474-303-10, 71474-303-05, view more
    71474-303-55, 71474-303-51
  • Packager: Molecular Biologicals, LLC
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated March 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Wound Matrix

    Rx Prescription Only
    Single Use

    STERILER

    C E
    0 1 2 3

  • CAUTION

    Federal (U.S.A.) law restricts this device to sale by or on the order of a physician(or properly licensed Healthcare practitioner).

  • INDICATIONS FOR USE

    Acute surgical wounds, donor sites/grafts, podiatric wounds, wound dehiscence, diabetic ulcers, traumatic wounds, first & second degree Burns, chronic vascular ulcers, venous ulcers, Pressure ulcers, partial & full thickness wounds.

  • SUGGESTED DIRECTIONS FOR USE

    NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE

    WOUND BED PREPARATION & APPLICATIONMATRIX CHANGES AND REAPPLICATIONS
    1. Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue.
    2. Cut the dry keramatrix® sheet into a piece slightly larger than the outline of the wound area. If the wound is larger than a single sheet then multiple sheets may be used,overlapping edges as necessary.
    3. For a wound with a low-level of exudate hydrate the matrix by soaking it in sterile saline solution for 2 minutes prior to application.
    4. Place the edge of the sheet in contact with intact tissue and smooth the matrix so that it contacts the underlying wound bed. If multiple matrices are used, overlap adjoining sheets to provide coverage of the entire wound. Secure with the preferred method of fixation[steri-strips, sutures, staples, clips}.
    5. After application use an appropriate, non-adherent, occlusive secondary dressing to maintain a moist environment. Ensure the matrix is well restrained.
    6.
    Change keramatrix® sheet as necessary every 4 to 5 days days or as determined by the healthcare provider. Do not remove existing gel or matrix areas. The matrix will caramelize into a gel and have a off white light brown color.
    7.
    Once cleansed with Sterile Saline solution keramatrix may be reapplied. Ensure that there are no bleeding areas and that the wound edges are clean.
    8.
    For a wound with a medium to high level of exudate, place the edge of the sheet in contact with intact tissue and smooth the so that it contacts the underlying wound bed. Small openings can be cut into the sheet prior to application to allow adequate drainage and ensure tissue matrix contact with the wound bed.
    9.
    Carefully document healing progression using customary healing parameters. Proceed with reapplication of appropriate non-adherent occlusive secondary dressing and maintain a moist environment.
    10.
    If infection, excessive redness, blistering or allergic reaction occurs the matrix material should be removed.
  • CONTRAINDICATIONS

    Any known sensitivity to keratin.

  • PRECAUTIONS

    Do not reuse or re-sterilize. Do not use if package is open or unsealed. Use prior to expiration date.

  • STORAGE

    Do not use if pouch has been opened or damaged. Should be stored at a clean, dry location at room temperature.

  • HOW SUPPLIED

    keramatrix is supplied in a clear pouch with labelled unit cartons.

    keramatrix 5cm ×5cm Individual unit71474-303-05
    keramatrix 5cm × 5cm Box of 5 units71474-303-55
    keramatrix 5cm × 5cm Box of 10 units71474-303-51
    keramatrix 10cm × 10cm Individual unit71474-303-01
    keramatrix 10cm × 10cm Box of 5 units71474-303-50
    keramatrix 10cm × 10cm Box of 10 units71474-303-10
  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Molecular Biologicals, LLC
    Pasadena, TX 77505 | 1-844-793-9933
    By Keraplast Research Limited
    Gerald St, Lincoln 7674 NZ

  • PRINCIPAL DISPLAY PANEL - 5 Matrix Package Box Label

    For Wounds & Burns
    Keramatrix®
    Enriched With Bioactive Keratin

    5x 5 Matrices
    NDC 71474-303-50
    10cm x 10cm (4" x 4")

    LOT EXP1220G3

    2020-12-31

    CE
    0123
    STERILE R

    Rx Only

    replicine™

    For Topical Use Only
    Store in dry conditions between 0°
    and 35°C (32° and 95° F).
    Do not use if the packaging has been
    damaged prior to use.
    Sterility is guaranteed until the packaging
    is first opened or damaged prior to use.
    Do not reuse or resterilize.
    See package insert for usage and
    complete Prescribing Information.

    MolecularBiologicals.com

    MOLECULAR BIOLOGICALS

    THE HEALING POWER OF NATURE

    Manufactured for:
    Molecular Biologicals, LLC
    Pasadena, TX 77505

    Manufactured by:
    Keraplast Research Limited
    Gerald St.
    Lincoln, 7674
    New Zealand (NZL)

    PRINCIPAL DISPLAY PANEL - 5 Matrix Package Box Label
  • INGREDIENTS AND APPEARANCE
    KERAMATRIX 
    dressing, wound, drug not applicable
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71474-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) (AMINO ACIDS, HAIR KERATIN - UNII:G46579QK1M) AMINO ACIDS, HAIR KERATIN100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71474-303-011 in 1 POUCH
    11 in 1 PACKAGE; Type 0: Not a Combination Product
    2NHRIC:71474-303-505 in 1 BOX
    25 in 1 PACKAGE; Type 0: Not a Combination Product
    3NHRIC:71474-303-1010 in 1 BOX
    310 in 1 PACKAGE; Type 0: Not a Combination Product
    4NHRIC:71474-303-051 in 1 POUCH
    41 in 1 PACKAGE; Type 0: Not a Combination Product
    5NHRIC:71474-303-555 in 1 BOX
    55 in 1 PACKAGE; Type 0: Not a Combination Product
    6NHRIC:71474-303-5110 in 1 BOX
    610 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXEMPT DEVICEFRO02/11/2009
    Labeler - Molecular Biologicals, LLC (079518915)
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