R.T.R.+ 80/20 RT0701M+GS50

GUDID 03700501812870

Synthetic Bone Substitute Granules

BIOMATLANTE

Bone matrix implant, synthetic

• Primary Device ID: 03700501812870
• NIH Device Record Key: a1f40641-d84c-424d-a6e8-51c5786558ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R.T.R.+ 80/20
• Version Model Number: RT0701M+GS50
• Catalog Number: RT0701M+GS50
• 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	03700501812870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093122

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

• 03700501813402 - RESORBA Synthetic Bone: 2024-05-27 Synthetic Bone Substitute - Resorbable Bone graft Granules 1-2 mm (1 cm3)
• 03700501813426 - RESORBA Synthetic Bone: 2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 60/40 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x2)
• 03700501813440 - RESORBA Synthetic Bone: 2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x1)
• 03700501813457 - RESORBA Synthetic Bone: 2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (1 cm3)
• 03700501813488 - RESORBA Synthetic Bone: 2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x1)
• 03700501813495 - RESORBA Synthetic Bone: 2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3) Syringe (x2)
• 03700501813549 - RESORBA Synthetic Bone: 2024-05-27 Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 1-2 mm (2 cm3)
• 03700501813501 - RESORBA Synthetic Bone: 2024-05-24 Injectable Bone Substitute 1G (80-200µm) Resorbable Bone Graft Injectable Bone Substitute 0.5 mL (x1)