OsteoFlo-G 151-012-130

GUDID 03700501806664

Synthetic Bone Substitute Granules 1-2 mm (2x15 cm3)

BIOMATLANTE

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 03700501806664
• NIH Device Record Key: 9f20e1a2-7b82-49c9-b152-497c559a6aee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoFlo-G
• Version Model Number: 151-012-130
• Catalog Number: 151-012-130
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700501806664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051774

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2022-01-07
• Device Publish Date: 2021-12-30

On-Brand Devices [OsteoFlo-G]

• 03700501806756: Synthetic Bone Substitute Stick 5 x 5 x 20mm (x4)
• 03700501806749: Synthetic Bone Substitute Stick 5 x 5 x 20mm (x2)
• 03700501806732: Synthetic Bone Substitute Stick 5 x 5 x 10mm (x4)
• 03700501806725: Synthetic Bone Substitute Stick 5 x 5 x 10mm (x2)
• 03700501806718: Synthetic Bone Substitute Granules 2-3 mm (2x15 cm3)
• 03700501806701: Synthetic Bone Substitute Granules 2-3 mm (15 cm3)
• 03700501806695: Synthetic Bone Substitute Granules 2-3 mm (10 cm3)
• 03700501806688: Synthetic Bone Substitute Granules 2-3 mm (5 cm3)
• 03700501806671: Synthetic Bone Substitute Granules 2-3 mm (2 cm3)
• 03700501806664: Synthetic Bone Substitute Granules 1-2 mm (2x15 cm3)
• 03700501806657: Synthetic Bone Substitute Granules 1-2 mm (10 cm3)