Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules

Basic Information

• Brand Name: Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules
• Primary DI: 00852108006282
• Version / Model: 04-030-02-MIL
• Catalog Number: 04-030-02-MIL
• Company Name: CYTOPHIL, INC.
• Labeler DUNS: 024222105
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-30
• Public Version: 3
• Public Version Date: 2020-01-27
• Public Version Status: Update
• Public Device Record Key: 514c39be-9efc-4f4f-a890-d7eedae9dcec
• Distribution End Date: 2020-01-26

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone Grafting Material, Synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47971	Dental bone matrix implant, synthetic	A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852108006282	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	3.0	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 32 Degrees Celsius