ReproBone

Basic Information

• Brand Name: ReproBone
• Primary DI: 05060171623403
• Version / Model: RBM3
• Company Name: CERAMISYS LTD
• Labeler DUNS: 423459374
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-31
• Public Version: 4
• Public Version Date: 2021-10-21
• Public Version Status: Update
• Public Device Record Key: b9393f7a-a465-4a69-ae76-27e92c61c06d
• Distribution End Date: 2021-10-20

Device Description

ReproBone synthetic bone graft substitute, Granules (0.8-1.5mm), 3.0cc

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
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060171623403	GS1

Premarket Submissions

Submission Number	Supplement Number
K103820	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius