PRONECONNECT CUSHION INSERT, SINGLE, M PC505CS

GUDID 00842430109263

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Head/neck procedure positioner face cushion

• Primary Device ID: 00842430109263
• NIH Device Record Key: e59dfdc9-3130-4c0a-aa8d-a114a9a85b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRONECONNECT CUSHION INSERT, SINGLE, M
• Version Model Number: PC505EA
• Catalog Number: PC505CS
• Company DUNS: 084527241
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com
• Phone: 1-800-777-4674
• Email: CustServ@mizuhosi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842430109263 [Primary]
GS1	10842430109260 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• CCX: Support, Patient Position

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-29

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

• 00842430109188 - PRONECONNECT PROTECTIVE HELMET: 2025-09-08
• 00842430109195 - PRONECONNECT ADJUSTABLE HELMET: 2025-09-08
• 00842430109201 - PRONECONNECT COMBO PACK 4L, 3M, 3S: 2025-09-08
• 00842430109218 - PRONECONNECT LOW PROFILE MIRROR: 2025-09-08
• 00842430109225 - PRONECONNECT ADJUSTABLE MIRROR: 2025-09-08
• 00842430109232 - PRONECONNECT MIRROR WITH POST HOLES: 2025-09-08
• 00842430109249 - PRONECONNECT TRIOS MIRROR PLATFORM: 2025-09-08
• 00842430109256 - PRONECONNECT CUSHION INSERT, SINGLE, S: 2025-09-08