ENT KIT- ear, nose, and throat surgical tray (kit)   
Centurion Medical Products

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ENT Kit

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

ENT KIT 
ear, nose, and throat surgical tray (kit) kit
Product 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, solution
Product Information
Item Code (Source) NDC:0409-4276
Route of Administration INFILTRATION DEA Schedule     
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

Revised: 10/2013
Document Id: 9dd2f27e-df44-4ffa-a0e2-048a3831ea13
Set id: e78fa5ab-eb94-4b22-88a6-ea1c8737dcfc
Version: 1
Effective Time: 20131001
 
Centurion Medical Products