Osteo-i Synthetic Biphasic Dental Bone Graft Granules OST413

GUDID 00852108006183

Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended 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: 00852108006183
• NIH Device Record Key: e01d88aa-6b01-4fca-acec-b434684d01e3
• Commercial Distribution Discontinuation: 2019-11-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Osteo-i Synthetic Biphasic Dental Bone Graft Granules
• Version Model Number: 03-030-01-SAS
• Catalog Number: OST413
• 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: 3 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852108006183 [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 Biphasic Dental Bone Graft Granules]

• 00852108006183: Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate inten
• 00852108006176: Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate inten
• 00852108006169: Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate inten