MBCP 0810B01

GUDID 00370050186091

Synthetic Resorbable Bone graft

BIOMATLANTE

Bone matrix implant, synthetic

• Primary Device ID: 00370050186091
• NIH Device Record Key: f7d18ef8-c0ae-4ad6-89e3-512d5a74343d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MBCP
• Version Model Number: 0810B01
• Catalog Number: 0810B01
• Company DUNS: 493710719
• Company Name: BIOMATLANTE
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370050186091 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-10

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