Mixing and Delivery System 44-000-00-AUX

GUDID B4474400000AUX0

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.

BONE SOLUTIONS, INC.

Bone graft delivery kit

• Primary Device ID: B4474400000AUX0
• NIH Device Record Key: cf7aaefa-7291-4973-a78b-debbf425b99f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mixing and Delivery System
• Version Model Number: AUX
• Catalog Number: 44-000-00-AUX
• Company DUNS: 003506272
• Company Name: BONE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4474400000AUX0 [Primary]

FDA Product Code

• FMF: Syringe, Piston

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: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [Mixing and Delivery System]

• B4474400000AUX0: The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au
• B447RM4405210: The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au
• B447RM4405110: The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au
• B447RM4405010: The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au
• B4477120010: The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au