PKIT HANA LATERAL SET WITH BOOT 6855L-6

GUDID 10842430115438

MIZUHO ORTHOPEDIC SYSTEMS, INC.

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Primary Device ID10842430115438
NIH Device Record Key36bb3882-1476-47c3-8dbb-c7e18f9e7ac4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePKIT HANA LATERAL SET WITH BOOT
Version Model Number6855L-1
Catalog Number6855L-6
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone1-800-777-4674
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
GS100842430115431 [Primary]
GS110842430115438 [Package]
Contains: 00842430115431
Package: CASE [6 Units]
In Commercial Distribution

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-11
Device Publish Date2021-05-03

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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
00842430103414 - UPPER ARM SUPPORT & PAD, REFURBISHED2023-09-27

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