HAND CONTROL HB54L FOR MARK II & III 9650-422

GUDID 00842430114069

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control Operating room equipment remote control
Primary Device ID00842430114069
NIH Device Record Key20947eb4-1a63-4419-a553-d86b36bc1c81
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAND CONTROL HB54L FOR MARK II & III
Version Model Number9650-422
Catalog Number9650-422
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]
GS100842430114069 [Primary]

FDA Product Code

GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
GDCTable, Operating-Room, Electrical
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 Date2021-01-13
Device Publish Date2021-01-05

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

00842430101236 - HANDPENDANT, RECONDITIONED,TRIOS, REFURB2021-01-13
00842430103513 - ASSEMBLY, CERVICAL LINKEAGE BAR, REFURB2021-01-13
00842430110788 - PROTECTORS, LEG SPAR BALL JOINT, 12/PR2021-01-13
00842430111822 - ARM BOARD MOUNTING BRACKET2021-01-13
00842430112003 - LEG SPAR, RIGHT2021-01-13
00842430112010 - KIT, FRU, CNTL BOX W/MNTS 120V REFURB2021-01-13
00842430112164 - LEG WEDGE FOAM PAD (PER PAIR)2021-01-13
00842430112744 - TRACK RACK2021-01-13

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