Label: GENERAL SURGERY TRAY- kit
- NHRIC Code(s): 24840-1521-1, 24840-1521-2
- NDC Code(s): 0168-0357-55
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated October 2, 2013
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- Description
- General Surgery Tray Primary Label
- Lidocaine and Prilocaine Label
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INGREDIENTS AND APPEARANCE
GENERAL SURGERY TRAY
tray, surgical kitProduct 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 creamProduct Information Item Code (Source) NDC:0168-0357 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 25 mg in 1 g PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) SODIUM HYDROXIDE (UNII: 55X04QC32I) Water (UNII: 059QF0KO0R) 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