MBCP 0112C01

GUDID 03700501800204

Synthetic Bone Substitute Wedge

BIOMATLANTE

Bone matrix implant, synthetic

• Primary Device ID: 03700501800204
• NIH Device Record Key: f4c2183c-3c1c-496f-8956-6b7125afcb06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MBCP
• Version Model Number: 0112C01
• Catalog Number: 0112C01
• Company DUNS: 493710719
• Company Name: BIOMATLANTE
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Device Dimensions

• Length: 12 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700501800204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051774

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: 2020-05-07
• Device Publish Date: 2020-04-29

On-Brand Devices [MBCP]

• 00370050186091: Synthetic Resorbable Bone graft
• 03700501806640: Synthetic Bone Substitute Stick
• 03700501803137: Synthetic Bone Substitute Stick
• 03700501803120: Synthetic Bone Substitute Stick
• 03700501803113: Synthetic Bone Substitute Stick
• 03700501800662: Synthetic Bone Substitute Granules
• 03700501800259: Synthetic Bone Substitute Cylinder
• 03700501800242: Synthetic Bone Substitute Cylinder
• 03700501800235: Synthetic Bone Substitute Cylinder
• 03700501800228: Synthetic Bone Substitute Cylinder
• 03700501800211: Synthetic Bone Substitute Cylinder
• 03700501800204: Synthetic Bone Substitute Wedge
• 03700501800198: Synthetic Bone Substitute Wedge
• 03700501800181: Synthetic Bone Substitute Wedge
• 03700501800174: Synthetic Bone Substitute Wedge
• 03700501800167: Synthetic Bone Substitute Wedge
• 03700501800150: Synthetic Bone Substitute Wedge
• 03700501800143: Synthetic Bone Substitute Wedge
• 03700501800136: Synthetic Bone Substitute Wedge
• 03700501800129: Synthetic Bone Substitute Wedge
• 03700501800112: Synthetic Bone Substitute Stick
• 03700501800105: Synthetic Bone Substitute Stick
• 03700501800099: Synthetic Bone Substitute Stick
• 03700501800082: Synthetic Bone Substitute Stick
• 03700501800068: Synthetic Bone Substitute Granules
• 03700501800051: Synthetic Bone Substitute Granules
• 03700501800044: Synthetic Bone Substitute Granules
• 03700501800037: Synthetic Bone Substitute Granules
• 03700501800020: Synthetic Bone Substitute Granules
• 03700501800013: Synthetic Bone Substitute Granules
• 03700501814133: Synthetic Bone Substitute Granules 0.5-1mm 3.15 cm3