RESORBA Synthetic Bone SB0401GS50

GUDID 03700501812795

Synthetic Bone Substitute Granules 0.5-1mm (0.5cc)

BIOMATLANTE

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 03700501812795
• NIH Device Record Key: 4c8d9cd3-7f13-4fdb-b1c0-da8f3552949b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESORBA Synthetic Bone
• Version Model Number: SB0401GS50
• Catalog Number: SB0401GS50
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700501812795 [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: 2021-06-18
• Device Publish Date: 2021-06-10

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)