Opus Mg Set - Mixing and Delivery System 712000

GUDID B4477120000

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: B4477120000
• NIH Device Record Key: c189583b-e961-4f76-85e3-6b312786b18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opus Mg Set - Mixing and Delivery System
• Version Model Number: AUX
• Catalog Number: 712000
• 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
• 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 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4477120000 [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: 2021-10-05
• Device Publish Date: 2021-09-27

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