T-Han Delivery System RM44-063

GUDID 00850080243152

The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

BONE SOLUTIONS, INC.

Orthopaedic coaxial injection applicator

• Primary Device ID: 00850080243152
• NIH Device Record Key: 179dadc7-ce62-4eda-8237-23564d81f14f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Han Delivery System
• Version Model Number: 4.2 x 350mm
• Catalog Number: RM44-063
• Company DUNS: 003506272
• Company Name: BONE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850080243152 [Primary]

FDA Product Code

• GEA: Cannula, Surgical, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-23
• Device Publish Date: 2026-02-13

On-Brand Devices [T-Han Delivery System]

• 00850080243169: The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or
• 00850080243152: The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or
• 00850080243145: The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or