Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules OST404

GUDID 00852108006190

Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.

CYTOPHIL, INC.

Dental bone matrix implant, synthetic

• Primary Device ID: 00852108006190
• NIH Device Record Key: 66701d27-2170-42ab-b88e-d3fa104f0aae
• Commercial Distribution Discontinuation: 2019-11-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules
• Version Model Number: 04-005-01-SAS
• Catalog Number: OST404
• Company DUNS: 024222105
• Company Name: CYTOPHIL, INC.
• Device Count: 1
• DM Exempt: false
• 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 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852108006190 [Primary]

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-30

On-Brand Devices [Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules]

• 00852108006206: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indica
• 00852108006190: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indica