PKIT, INDIV W/SHEARGARD, SST-3000 (1) 5819

GUDID 10842430111539

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set Surgical linen/cushion set
Primary Device ID10842430111539
NIH Device Record Key3abc53c8-5a13-4692-aa91-e0ad02afb525
Commercial Distribution StatusIn Commercial Distribution
Brand NamePKIT, INDIV W/SHEARGARD, SST-3000 (1)
Version Model Number5819-1
Catalog Number5819
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
GS100842430111532 [Primary]
GS110842430111539 [Package]
Contains: 00842430111532
Package: multi-pack [6 Units]
In Commercial Distribution

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-05-20
Device Publish Date2022-01-05

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

10842430111539 - PKIT, INDIV W/SHEARGARD, SST-3000 (1)2024-05-20
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

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