GENERAL SURGERY TRAY- tray, surgical   
Centurion Medical Products

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General Surgery Kit

Description

NOT FOR OPHTHALMIC USE
FOR EXTERNAL USE ONLY
Rx only

General Surgery Tray Primary Label

NS-GSURGERY-LIDO.jpg

Lidocaine and Prilocaine Label

XYLCREAM.jpg

GENERAL SURGERY TRAY 
tray, surgical kit
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NHRIC:24840-1521
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NHRIC:24840-1521-1 1 in 1 PACKAGE, COMBINATION
2 NHRIC:24840-1521-2 1 in 1 CASE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 5 g
Part 1 of 1
LIDOCAINE AND PRILOCAINE 
lidocaine and prilocaine cream
Product Information
Item Code (Source) NDC:0168-0357
Route of Administration Topical DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 25 mg  in 1 g
PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE 25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0168-0357-55 5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076453 08/18/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
exempt device LRP 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
E. Fougera & Co. 043838424 manufacture

Revised: 10/2013
Document Id: e1185ced-4347-4b18-abb8-59adb74d68ed
Set id: 88c0ffed-a553-444e-9800-6c8c80df7690
Version: 1
Effective Time: 20131002
 
Centurion Medical Products