nanOss Loaded Advanced Bone Graft Substitute Kit 90-200-05K

GUDID 00849777012447

Advanced Bone Graft Substitute in Mixing Chamber, Mixing Chamber cap, Hydration Syringe, Graft Applicator Body, Applicator Piston, Adapter Cap, 5cc

Xtant Medical, Inc.

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• Primary Device ID: 00849777012447
• NIH Device Record Key: dc85611a-808d-436f-8f16-8b28caf32d4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nanOss Loaded Advanced Bone Graft Substitute Kit
• Version Model Number: 90-200-05K
• Catalog Number: 90-200-05K
• 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	00849777012447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141600

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 Loaded Advanced Bone Graft Substitute Kit]

• 00849777012454: Advanced Bone Graft Substitute in Mixing Chamber, Mixing Chamber cap, Hydration Syringe, Graft A
• 00849777012447: Advanced Bone Graft Substitute in Mixing Chamber, Mixing Chamber cap, Hydration Syringe, Graft A