Label: GENERAL SURGERY TRAY- kit

  • 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 October 2, 2013

If you are a consumer or patient please visit this version.

  • Description

    NOT FOR OPHTHALMIC USE
    FOR EXTERNAL USE ONLY
    Rx only

  • General Surgery Tray Primary Label

    NS-GSURGERY-LIDO.jpg

  • Lidocaine and Prilocaine Label

    XYLCREAM.jpg

  • INGREDIENTS AND APPEARANCE
    GENERAL SURGERY TRAY 
    tray, surgical kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1521
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24840-1521-11 in 1 PACKAGE, COMBINATION
    2NHRIC:24840-1521-21 in 1 CASE
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 5 g
    Part 1 of 1
    LIDOCAINE AND PRILOCAINE 
    lidocaine and prilocaine cream
    Product Information
    Item Code (Source)NDC:0168-0357
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE25 mg  in 1 g
    PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0357-555 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07645308/18/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceLRP01/01/2013
    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
    E. Fougera & Co.043838424manufacture