nanOss 3D Plus Advanced Bone Graft Substitute 90-400-251008

GUDID 00849777012515

Advanced Bone Graft Substitute 20cc

Xtant Medical, Inc.

Bone matrix implant, composite

• Primary Device ID: 00849777012515
• NIH Device Record Key: 667c6e7b-8098-4c7d-9e91-73ecb1c385fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nanOss 3D Plus Advanced Bone Graft Substitute
• Version Model Number: 90-400-251008
• Catalog Number: 90-400-251008
• Company DUNS: 119238245
• Company Name: Xtant Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849777012515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132050

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [nanOss 3D Plus Advanced Bone Graft Substitute ]

• 00849777012539: Advanced Bone Graft Substitute 10cc
• 00849777012522: Advanced Bone Graft Substitute 5cc
• 00849777012515: Advanced Bone Graft Substitute 20cc
• 00849777012508: Advanced Bone Graft Substitute 10cc