ZENTRUM LEG SECTION, LEFT, EU 8000-22-E

GUDID 00842430108709

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Universal operating table top
Primary Device ID00842430108709
NIH Device Record Keye6a897bf-031a-4908-8e6f-30e6ac142bf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameZENTRUM LEG SECTION, LEFT, EU
Version Model Number8000-22-E
Catalog Number8000-22-E
Company DUNS084527241
Company NameMIZUHO ORTHOPEDIC SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com
Phone1-800-777-4674
EmailCustServ@mizuhosi.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100842430108709 [Primary]

FDA Product Code

GDCTable, Operating-Room, Electrical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-28
Device Publish Date2018-11-27

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