AVRA FOOT 3IN SKYTRON 3501,3600,3602 69483AVF

GUDID 00842430110368

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Operating table mattress, pressure-sensing
Primary Device ID00842430110368
NIH Device Record Key49c6351f-f97d-4678-84fd-16d6ad2a1452
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVRA FOOT 3IN SKYTRON 3501,3600,3602
Version Model Number69483AVF
Catalog Number69483AVF
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
EmailCustServ@mizuhosi.com
Phone1-888-777-4674
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
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 Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 105 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100842430110368 [Primary]

FDA Product Code

JFCSystem, Pressure Measurement, Intermittent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-28
Device Publish Date2021-06-18

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

10842430111539 - PKIT, INDIV W/SHEARGARD, SST-3000 (1)2024-05-20
00842430116322 - AQUARI IMMERSION CONTROLLER REFURB2024-03-15
00842430113727 - FOOT SUPPORT ASSEMBLY2024-03-14
00842430101212 - Pad Set For GST Tempur-Pedic, 76MM2023-09-27
00842430101311 - SPAR,LEG,RIGHT RADIOLUCENT,REFURBISHED2023-09-27
00842430101328 - SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHED2023-09-27
00842430101335 - SPAR ASSEMBLY, RIGHT, REFURBISHED2023-09-27
00842430101342 - SPAR ASSEMBLY, LEFT, REFURBISHED2023-09-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.