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

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ENT Kit

Description


Aqueous Solution for Topical Use

and Retrobulbar Injection

Rx only

ENT Kit Primary Label

S_ENT_LIDO.jpg

Lidocaine Hydrochloride Label

XYL283.jpg

ENT KIT 
ear, nose, and throat surgical tray (kit) kit
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1313
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NHRIC:24840-1313-1 1 in 1 PACKAGE, COMBINATION
2 NHRIC:24840-1313-2 1 in 1 CASE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 AMPULE 5 mL
Part 1 of 1
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride anhydrous injection, solution
Product Information
Item Code (Source) NDC:0409-4283
Route of Administration RETROBULBAR, Topical DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0409-4283-01 5 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088295 03/24/2010
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: 9c2206e3-d2e0-4f79-a520-eb8b953f5f81
Set id: cedf83c9-dd60-4d2e-871a-e6c0b8b9fafe
Version: 1
Effective Time: 20131002
 
Centurion Medical Products