Label: ENT KIT- kit

  • Category: MEDICAL DEVICE

Drug Label Information

Updated October 1, 2013

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  • DESCRIPTION

    AQUEOUS SOLUTIONS FOR INFILTRATION

    AND NERVE BLOCK

    Ampul

    Plastic Multiple-Dose Fliptop Vial

    Glass Teartop Vial

    Rx only

  • ENT Tray Primary Label

    NS-ENT-LIDO.jpg

  • Lidocaine 1%, 20 ml Label

    XYL220 Label.jpg

  • INGREDIENTS AND APPEARANCE
    ENT KIT 
    ear, nose, and throat surgical tray (kit) kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1308
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1308-21 in 1 CASE
    1NHRIC:24840-1308-11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 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 AdministrationINFILTRATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 7 mg  in 1 mL
    Water (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0409-4276-0120 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08040803/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceOGR01/01/2013
    Labeler - Centurion Medical Products (017246562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Centurion Medical Products017246562manufacture, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Centurion Medical Products148522279manufacture, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Centurion Medical Products626660810manufacture, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Hospira093132819manufacture