PRONECONNECT CUSHION INSERT, SINGLE, S PC507CS

GUDID 00842430109256

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Head/neck procedure positioner face cushion
Primary Device ID00842430109256
NIH Device Record Key9e2c8e53-3dff-46b0-a2b4-5a3ae0c9f25c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRONECONNECT CUSHION INSERT, SINGLE, S
Version Model NumberPC507EA
Catalog NumberPC507CS
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 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
GS100842430109256 [Primary]
GS110842430109253 [Package]
Package: Case [10 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 Date2025-09-08
Device Publish Date2025-08-29

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

00842430109188 - PRONECONNECT PROTECTIVE HELMET2025-09-08
00842430109195 - PRONECONNECT ADJUSTABLE HELMET2025-09-08
00842430109201 - PRONECONNECT COMBO PACK 4L, 3M, 3S2025-09-08
00842430109218 - PRONECONNECT LOW PROFILE MIRROR2025-09-08
00842430109225 - PRONECONNECT ADJUSTABLE MIRROR2025-09-08
00842430109232 - PRONECONNECT MIRROR WITH POST HOLES2025-09-08
00842430109249 - PRONECONNECT TRIOS MIRROR PLATFORM2025-09-08
00842430109256 - PRONECONNECT CUSHION INSERT, SINGLE, S2025-09-08
00842430109256 - PRONECONNECT CUSHION INSERT, SINGLE, S2025-09-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.