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 TypeMEDICAL DEVICEItem Code (Source)NHRIC:24840-1313
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:24840-1313-11 in 1 PACKAGE, COMBINATION
2NHRIC:24840-1313-21 in 1 CASE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 AMPULE 5 mL
Part 1 of 1
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride anhydrous injection, solution
Product Information
Item Code (Source)NDC:0409-4283
Route of AdministrationRETROBULBAR, TopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-4283-015 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08829503/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceOGR01/01/2013
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
Hospira093132819manufacture

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