RESORBA Synthetic Bone SB0701M+G01

GUDID 03700501813457

Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (1 cm3)

BIOMATLANTE

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 03700501813457
• NIH Device Record Key: c7666109-eb14-4aa9-8064-4f22f216e6ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESORBA Synthetic Bone
• Version Model Number: SB0701M+G01
• Catalog Number: SB0701M+G01
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700501813457 [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: 2024-05-27
• Device Publish Date: 2024-05-17

On-Brand Devices [RESORBA Synthetic Bone]

• 03700501813280: Synthetic Bone Substitute Cylinder Diam 14mm, Height 20mm
• 03700501813273: Synthetic Bone Substitute Cylinder Diam 10mm, Height 20mm
• 03700501813266: Synthetic Bone Substitute Cylinder Diam 12mm, Height 20mm
• 03700501813259: Synthetic Bone Substitute Wedge base 8mm (x1)
• 03700501813242: Synthetic Bone Substitute Wedge base 10mm (x1)
• 03700501813235: Synthetic Bone Substitute Wedge base 12mm (x1)
• 03700501813228: Synthetic Bone Substitute Cylinder Diam 8mm, Height 20mm
• 03700501813211: Synthetic Bone Substitute Cylinder Diam 9.5mm, Height 20mm
• 03700501813136: Synthetic Bone Substitute Wedge base 6mm (x1)
• 03700501813129: Synthetic Bone Substitute Wedge base 5mm (x1)
• 03700501813112: Synthetic Bone Substitute Granules 2-3mm (16cc)
• 03700501813105: Synthetic Bone Substitute Granules 2-3mm (2cc)
• 03700501813099: Synthetic Bone Substitute Sticks 5x5x20mm (x4)
• 03700501813082: Synthetic Bone Substitute Sticks 5x5x20mm (x2)
• 03700501813075: Synthetic Bone Substitute Sticks 5x5x10mm (x4)
• 03700501813068: Synthetic Bone Substitute Sticks 5x5x10mm (x2)
• 03700501813037: Synthetic Bone Substitute Rounded wedge 14mm (x1)
• 03700501813020: Synthetic Bone Substitute Granules 1-2mm syringe (10cc)
• 03700501813013: Synthetic Bone Substitute Granules 1-2mm syringe (5cc)
• 03700501813006: Synthetic Bone Substitute Stick 10x10x40mm (x1)
• 03700501812993: Synthetic Bone Substitute Stick 10x20x50mm (x1)
• 03700501812986: Synthetic Bone Substitute Stick 10x30x30mm (x1)
• 03700501812979: Synthetic Bone Substitute Stick 12x25x25mm (x1)
• 03700501812962: Synthetic Bone Substitute Stick 10x10x10mm (x1)
• 03700501812955: Synthetic Bone Substitute Granules 2-3mm (20cc)
• 03700501812948: Synthetic Bone Substitute Granules 2-3mm (30cc)
• 03700501812931: Synthetic Bone Substitute Granules 1-2mm (30cc)
• 03700501812924: Synthetic Bone Substitute Rounded wedge 12mm (x1)
• 03700501812917: Synthetic Bone Substitute Rounded wedge 10mm (x1)
• 03700501812900: Synthetic Bone Substitute Rounded wedge 8mm (x1)
• 03700501812894: Synthetic Bone Substitute Rounded wedge 6mm (x1)
• 03700501812856: Synthetic Bone Substitute Granules 2-3mm (10cc)
• 03700501812849: Synthetic Bone Substitute Granules 1-2mm (10cc)
• 03700501812832: Synthetic Bone Substitute Granules 1-2mm (5cc)
• 03700501812825: Synthetic Bone Substitute Granules 2-3mm (5cc)
• 03700501812818: Synthetic Bone Substitute Granules 1-2mm (2cc)
• 03700501812801: Synthetic Bone Substitute Granules 0.5-1mm (0.5cc)
• 03700501812795: Synthetic Bone Substitute Granules 0.5-1mm (0.5cc)
• 03700501812788: Synthetic Bone Substitute Granules 0.5-1mm (1cc)
• 03700501813518: Injectable Bone Substitute 1G (80-200µm) Resorbable Bone Graft Injectable Bone Substitute 0.5 m
• 03700501813501: Injectable Bone Substitute 1G (80-200µm) Resorbable Bone Graft Injectable Bone Substitute 0.5 m
• 03700501813549: Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 1-2 mm (2 cm3)
• 03700501813495: Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3
• 03700501813488: Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3
• 03700501813457: Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (1 cm3)
• 03700501813440: Synthetic Bone Substitute HA/BTCP ratio 20/80 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3
• 03700501813426: Synthetic Bone Substitute HA/BTCP ratio 60/40 Resorbable Bone Graft Granules 0.5-1 mm (0.5 cm3)
• 03700501813402: Synthetic Bone Substitute - Resorbable Bone graft Granules 1-2 mm (1 cm3)