GENERAL SURGERY KIT- general surgery tray (kit)   
Centurion Medical Products

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General Surgery Kit

DESCRIPTION

Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations. Sodium metabisulfate 0.5 mg/ml and citric acid, anhydrous 0.2 mg/ml added as stabilizers. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). Single dose ampuls and vials containno bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type.

Lidocaine Label

lidocaine and epi.jpg

General Surgery Procedure Label

NS-OBGYN-LIDO.jpgMM

GENERAL SURGERY KIT 
general surgery tray (kit) kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1511
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1511-210 in 1 CASE
1NHRIC:24840-1511-11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 AMPULE 5 mL
Part 1 of 1
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 
lidocaine hydrochloride anhydrous and epinephrine injection, solution
Product Information
Item Code (Source)NDC:0409-1209
Route of AdministrationEPIDURAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS15 mg  in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE5 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 6.5 mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.5 mg  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.2 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-1209-015 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08857104/05/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceLRO01/01/2012
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
Hospira Inc093132819manufacture

Revised: 9/2012
Document Id: 93da5f69-e54c-4547-8f28-2101562f452b
Set id: fc5cafa6-9a20-4a1b-9227-d41db6cb5a97
Version: 1
Effective Time: 20120921
 
Centurion Medical Products