Mixing and Delivery System

Basic Information

• Brand Name: Mixing and Delivery System
• Primary DI: B447RM4405010
• Version / Model: Beat Mat Pak
• Catalog Number: RM 44-050
• Company Name: BONE SOLUTIONS, INC.
• Labeler DUNS: 003506272
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-30
• Public Version: 2
• Public Version Date: 2020-09-29
• Public Version Status: Update
• Public Device Record Key: 9d499bb9-98b5-4476-848e-65be0cb7c6a8

Device Description

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

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46119	Bone graft delivery kit	A collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B447RM4405010	HIBCC

Customer Contacts

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