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FastStat (CAO Group, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 3 SYRINGE, PLASTIC in 1 KIT (14060-010-03) > 3 g in 1 SYRINGE, PLASTIC Label Information
GEL 20 SYRINGE, PLASTIC in 1 KIT (14060-010-02) > 3 g in 1 SYRINGE, PLASTIC Label Information

Complete FastStat Information

  • DESCRIPTION

    FastStatâ„¢ topical hemostat is an increased activity coagulative hemostatic gel containing 10% ferric sulfate, built around a novel organic polymer. This unique formulation is easy to use and rinses clean. FastStat hemostatic gel provides superior hemostasis at a much lower concentration of ferric sulfate. Because it rinses cleanly, FastStat minimizes post-operative black discoloration under restorations.
  • CONTRAINDICATIONS

    • Not for use in patients with known sensitivity or allergies to iron or iron salts.
    • Not for use in pulpectomy procedures.
    • Ensure the material has had time to react with the blood and exposed capillaries before proceeding with subsequent procedures.

  • STORAGE AND HANDLING

    • Do not store above 100°F (38°C). Do not freeze. Do not use beyond indicated shelf life.
    • Do not use if the packaging has been damaged, or if the seals are found to be broken or open.
    • Shelf Life: 2 years

  • DOSAGE & ADMINISTRATION

    1. Twist on FE ScrubTipâ„¢ brush for easy application.
    2. Deliver hemostatic gel directly to bleeding areas. Use the fiber-flocked ball to burnish/rub gel into bleeding capillaries. Continue to burnish until bleeding stops.
    3. When control of bleeding is achieved, use suction and heavy air/water spray to remove coagulum and residual gel from surface.
    4. If bleeding restarts, repeat application and burnishing.

  • WARNINGS AND PRECAUTIONS

    Caution: Federal law restricts this device to sale by or on the order of a licensed professional.

    Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

    Manufactured by CAO (China) Medical Equipment Co,. Ltd. for CAO Group, Inc.

    P 877.236.4408 F 801.256.9287
    4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A.
    www.caogroup.com

    SAL-CAI007C.1/23SEP2010


  • DESCRIPTION

    BACK PANEL INTRO KIT OUTER PACKAGING

    PACKAGE CONTENTS: 3) 3cc preloaded syringes, 2) packs of 25 FEscrubTipsâ„¢
    See package insert for dosage information. Rx Only.
    Dispose of properly after use. For complete safety information see product MSDS.
    Do not use if the packaging has been damaged, or if the safety seals are found to be broken.

    REORDER #
    006-00075

    Manufactured by CAO (China)
    Medical Equipment Co., Ltd. for CAO Group, Inc.

    4628 West Skyhawk Drive
    West Jordan, UT 84084
    U.S.A.
    877-236-4408 (tel)
    801-256-9287 (fax)
    www.caogroup.com

    STORAGE: [32°F/0°C to 100°F/38°C]

    TO REORDER:
    Henry Schein
    1.800.372.4346

    Expiration Date: [lot and date label]

    [BARCODE #: 872320000486]

    MADE IN CHINA

    PAK-CT0013D.1/23SEP2010


  • DESCRIPTION

    BACK PANEL REFILL KIT OUTER PACKAGING

    PACKAGE CONTENTS: 20) 3cc preloaded syringes, 1) packs of 100 FEscrubTipsâ„¢
    See package insert for dosage information. Rx Only.
    Dispose of properly after use. For complete safety information see product MSDS.
    Do not use if the packaging has been damaged, or if the safety seals are found to be broken.

    REORDER #
    006-00076

    Manufactured by CAO (China)
    Medical Equipment Co., Ltd. for CAO Group, Inc.

    4628 West Skyhawk Drive
    West Jordan, UT 84084
    U.S.A.
    877-236-4408 (tel)
    801-256-9287 (fax)
    www.caogroup.com

    STORAGE: [32°F/0°C to 100°F/38°C]

    TO REORDER:
    Henry Schein
    1.800.372.4346

    Expiration Date: [lot and date label]

    [BARCODE #: 872320000493]

    MADE IN CHINA

    PAK-CT0014D.1/23SEP2010


  • DESCRIPTION

    SIDE PANEL INTRO KIT OUTER PACKAGING

    FastStat

    Topical Hemostat

    Ingredients: water/eau, ferric sulfate, proprietary polymer thickener

    NDC# 1404001003


  • DESCRIPTION

    SIDE PANEL REFILL KIT OUTER PACKAGING

    FastStat

    Topical Hemostat

    Ingredients: water/eau, ferric sulfate, proprietary polymer thickener

    NDC# 1404001002


  • PRINCIPAL DISPLAY PANEL

    FastStat

    Topical Hemostat

    Stops Bleeding. Rinses Clean.

    Introductory Kit

    Net Qty, 3) 3cc preloaded syringes
    Active ingredient: Ferric sulfate, 10%

    Intro Kit Principal Panel


  • PRINCIPAL DISPLAY PANEL

    FastStat

    Topical Hemostat

    Stops Bleeding. Rinses Clean.

    Introductory Kit

    Net Qty, 20) 3cc preloaded syringes
    Active ingredient: Ferric sulfate, 10%

    Refill Kit Principal Panel


  • INGREDIENTS AND APPEARANCE
    FASTSTAT  TOPICAL HEMOSTAT
    ferric sulfate gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14060-010
    Route of Administration INTRAGINGIVAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ferric Sulfate (UNII: 3HWS7HF5XD) (Ferric Cation - UNII:91O4LML611) Ferric Cation 142 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14060-010-03 3 in 1 KIT
    1 3 g in 1 SYRINGE, PLASTIC
    2 NDC:14060-010-02 20 in 1 KIT
    2 3 g in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/01/2010
    Labeler - CAO Group, Inc. (102422578)
    Registrant - CAO Group, Inc. (102422578)