R.T.R.+ 40/60 RT0401GS50

GUDID 03700501812863

Synthetic Bone Substitute Granules

BIOMATLANTE

Bone matrix implant, synthetic

• Primary Device ID: 03700501812863
• NIH Device Record Key: b5b836d6-ec82-4421-9205-463cd19b5eb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R.T.R.+ 40/60
• Version Model Number: RT0401GS50
• Catalog Number: RT0401GS50
• 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

• Total Volume: 0.5 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700501812863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051885

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2020-03-05
• Device Publish Date: 2020-02-26

Devices Manufactured by BIOMATLANTE

• 03700501814133 - MBCP: 2024-04-10 Synthetic Bone Substitute Granules 0.5-1mm 3.15 cm3
• 03700501806657 - OsteoFlo-G: 2022-01-07 Synthetic Bone Substitute Granules 1-2 mm (10 cm3)
• 03700501806664 - OsteoFlo-G: 2022-01-07 Synthetic Bone Substitute Granules 1-2 mm (2x15 cm3)
• 03700501806671 - OsteoFlo-G: 2022-01-07 Synthetic Bone Substitute Granules 2-3 mm (2 cm3)
• 03700501806688 - OsteoFlo-G: 2022-01-07 Synthetic Bone Substitute Granules 2-3 mm (5 cm3)
• 03700501806695 - OsteoFlo-G: 2022-01-07 Synthetic Bone Substitute Granules 2-3 mm (10 cm3)
• 03700501806701 - OsteoFlo-G: 2022-01-07 Synthetic Bone Substitute Granules 2-3 mm (15 cm3)
• 03700501806718 - OsteoFlo-G: 2022-01-07 Synthetic Bone Substitute Granules 2-3 mm (2x15 cm3)