Label: ENT KIT- ear, nose, and throat surgical tray (kit)

  • NDC Code(s): 0409-4276-01, 24840-1308-1, 24840-1308-2
  • Packager: Centurion Medical Products
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated 10/13

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  • DESCRIPTION

    AQUEOUS SOLUTIONS FOR INFILTRATION

    AND NERVE BLOCK

    Ampul

    Plastic Multiple-Dose Fliptop Vial

    Glass Teartop Vial

    Rx only

    Close
  • ENT Tray Primary Label
  • Lidocaine 1%, 20 ml Label
  • INGREDIENTS AND APPEARANCE
    ENT KIT 
    ear, nose, and throat surgical tray (kit) kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1308
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:24840-1308-2 1 in 1 CASE
    1 NHRIC:24840-1308-1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 VIAL, MULTI-DOSE 20 mL
    Part 1 of 1
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride anhydrous injection, solution
    Product Information
    Item Code (Source) NDC:0409-4276
    Route of Administration INFILTRATION DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE 7 mg  in 1 mL
    Water  
    SODIUM HYDROXIDE  
    HYDROCHLORIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0409-4276-01 20 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA080408 03/30/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    exempt device OGR 01/01/2013
    Labeler - Centurion Medical Products (017246562)
    Establishment
    Name Address ID/FEI Business Operations
    Centurion Medical Products 017246562 manufacture, repack
    Establishment
    Name Address ID/FEI Business Operations
    Centurion Medical Products 148522279 manufacture, repack
    Establishment
    Name Address ID/FEI Business Operations
    Centurion Medical Products 626660810 manufacture, repack
    Establishment
    Name Address ID/FEI Business Operations
    Hospira 093132819 manufacture
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