Label: ENT KIT- kit
- NHRIC Code(s): 24840-1308-2, 24840-1308-1
- NDC Code(s): 0409-4276-01
- Packager: Centurion Medical Products
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated October 1, 2013
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- Official Label (Printer Friendly)
- DESCRIPTION
- ENT Tray Primary Label
- Lidocaine 1%, 20 ml Label
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INGREDIENTS AND APPEARANCE
ENT KIT
ear, nose, and throat surgical tray (kit) kitProduct 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, solutionProduct Information Item Code (Source) NDC:0409-4276 Route of Administration INFILTRATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 7 mg in 1 mL Water (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) 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
