PRONECONNECT ADJUSTABLE MIRROR

Basic Information

• Brand Name: PRONECONNECT ADJUSTABLE MIRROR
• Primary DI: 00842430109225
• Version / Model: PC590M
• Catalog Number: PC590M
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-29
• Public Version: 1
• Public Version Date: 2025-09-08
• Public Version Status: New
• Public Device Record Key: b4384d21-307f-4a01-8f22-afb7a47356a2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66584	Headrest mirrored base	A flat reflective component of a headrest (attached to an operating/examination table or freestanding) intended to mount to the bottom of the patient-contact component of the headrest to enable a healthcare professional to view the face of an anaesthetized patient in prone position for visual monitoring (e.g., of patient eyes and tubing placement). It is a mirrored base with mounting points which may be adjusted to modify the height of the headrest. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430109225	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]