HANA/PROFX TRACTION BOOT XLARGE (pr), REFURBISHED 6850-487

GUDID 00842430103612

Left and Right boots

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Traction boot

• Primary Device ID: 00842430103612
• NIH Device Record Key: af620ef8-9286-45c2-a2ca-f3ef43b627ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANA/PROFX TRACTION BOOT XLARGE (pr), REFURBISHED
• Version Model Number: 6850-487R
• Catalog Number: 6850-487
• 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: false
• 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: false
• 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
• 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	00842430103612 [Primary]

FDA Product Code

• JEA: Table, Surgical With Orthopedic Accessories, Ac-Powered

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: 2022-05-26
• Device Publish Date: 2022-05-18

Devices Manufactured by MIZUHO ORTHOPEDIC SYSTEMS, INC.

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• 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