Label: GENERAL SURGERY TRAY- tray, surgical   

  • NDC Code(s): 0168-0357-55, 24840-1521-1, 24840-1521-2
  • 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

    NOT FOR OPHTHALMIC USE
    FOR EXTERNAL USE ONLY
    Rx only

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  • General Surgery Tray Primary Label
  • Lidocaine and Prilocaine Label
  • INGREDIENTS AND APPEARANCE
    GENERAL SURGERY TRAY 
    tray, surgical kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1521
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:24840-1521-1 1 in 1 PACKAGE, COMBINATION
    2 NHRIC:24840-1521-2 1 in 1 CASE
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 5 g
    Part 1 of 1
    LIDOCAINE AND PRILOCAINE 
    lidocaine and prilocaine cream
    Product Information
    Item Code (Source) NDC:0168-0357
    Route of Administration Topical DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (LIDOCAINE) LIDOCAINE 25 mg  in 1 g
    PRILOCAINE (PRILOCAINE) PRILOCAINE 25 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)  
    SODIUM HYDROXIDE  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0357-55 5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076453 08/18/2003
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    exempt device LRP 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
    E. Fougera & Co. 043838424 manufacture
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