PKIT HANA DISTRACTION PAD BASIC TRC 6855DPB-5

GUDID 10842430115391

MIZUHO ORTHOPEDIC SYSTEMS, INC.

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Primary Device ID10842430115391
NIH Device Record Key9559cacd-a1de-4094-b2b2-69189ea74894
Commercial Distribution StatusIn Commercial Distribution
Brand NamePKIT HANA DISTRACTION PAD BASIC TRC
Version Model Number6855DPB-1
Catalog Number6855DPB-5
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842430115394 [Primary]
GS110842430115391 [Package]
Contains: 00842430115394
Package: case [5 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 Date2021-05-04
Device Publish Date2021-04-26

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

10842430115377 - PKIT HANA DISTRACTION PAD HIP ARTHR2021-05-04
10842430115384 - PKIT HANA DISTRACTION PAD AATHA KIT2021-05-04
10842430115391 - PKIT HANA DISTRACTION PAD BASIC TRC2021-05-04
10842430115391 - PKIT HANA DISTRACTION PAD BASIC TRC2021-05-04
00842430115448 - AIR BARRIER SYSTEM NOZZLE2021-04-30
10842430115308 - PKIT HANA DISTRACTION PAD W/STRAP 2021-04-15
10842430115407 - PKIT HANA SUPINE, W/ BOOT, NO HEAD2021-03-02
00842430115417 - PKIT HANA SUPINE, NO HEAD, NO BOOT2021-03-02
00842430115479 - STRAP, POSITIONING2021-03-02

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