ORASTRUCT Orastruct-SYR-0.5

GUDID 03700501807197

Synthetic Resorbable Bone Graft Granules

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

• Primary Device ID: 03700501807197
• NIH Device Record Key: ad852b3c-2215-49bd-a13f-05f0e857c5ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORASTRUCT
• Version Model Number: Orastruct-SYR-0.5
• Catalog Number: Orastruct-SYR-0.5
• 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

Device Dimensions

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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700501807197 [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: 2021-01-26
• Device Publish Date: 2021-01-18

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)