HANA SSXT- AA THA UNIT, MOT, JP RAILS

GUDID 00842430103155

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Operating table orthopaedic extension
Primary Device ID00842430103155
NIH Device Record Key0e03a9db-0d87-412f-960e-c55aa074e2b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANA SSXT- AA THA UNIT, MOT, JP RAILS
Version Model Number6879-1
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 Kittrue
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

Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
EmailCustServ@mizuhosi.com
Phone800-777-4764
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 TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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
GS100842430103155 [Primary]

FDA Product Code

JEATable, Surgical With Orthopedic Accessories, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-22
Device Publish Date2022-02-14

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.