PRONECONNECT COMBO PACK 4L, 3M, 3S

Basic Information

• Brand Name: PRONECONNECT COMBO PACK 4L, 3M, 3S
• Primary DI: 00842430109201
• Version / Model: PC-COMBO
• Catalog Number: PC-COMBO
• 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: d6ba7ad1-03df-4617-baa1-9ce5feb4e3d0

Device Characteristics

• Single Use: Yes
• 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
67493	Head/neck procedure positioner face cushion	A cushion intended to be placed in a head/neck positioner (not included) in which the patient’s face lies to ensure support, positioning, and immobilization of the head, neck, and cervical spine during intraoperative and/or diagnostic procedures where the prone position is needed (e.g., spine or brain surgery); it is not intended to be used without the positioner (i.e., it is not a headrest). The positioner/cushion may be attached to an operating/examination table or be freestanding. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430109201	GS1

Customer Contacts

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