SHEARGUARD®, CHEST PILLOWS 6988SG-6

GUDID 00842430114519

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use
Primary Device ID00842430114519
NIH Device Record Keybfe25569-367f-41fd-a90c-d7ecf7ab7e2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHEARGUARD®, CHEST PILLOWS
Version Model Number5880-119
Catalog Number6988SG-6
Company DUNS084527241
Company NameMIZUHO ORTHOPEDIC SYSTEMS, INC.
Device Count6
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430114519 [Unit of Use]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]
GS100842430115042 [Primary]

FDA Product Code

KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical
KMEBedding, Disposable, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

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00842430101663 - TABLE, ProFx, REFURBISHED2020-09-17
00842430101717 - TABLE, INSITE2020-09-17
00842430101977 - TABLE, INSITE, REFURBISHED2020-09-17
00842430102455 - CART, ORTHO EQUIPMENT, TRIOS,REFURBISHED2020-09-17
00842430103490 - 10mm WELL HIP FIXATION FRAME (6850), REFURB2020-09-17
00842430103636 - ASSY, SPAR LIFT ASSIST DEVICE, REFURB2020-09-17
00842430103681 - SIDE RAIL CLAMP 6 IN., REFURBISHED2020-09-17

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