Shefabone™ SCPC-1

GUDID 05060517850005

Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone graft substitute composed of two phases: sodium calcium phosp

SHEFABONE INC

Dental bone matrix implant, synthetic

• Primary Device ID: 05060517850005
• NIH Device Record Key: af7e9331-40b9-44d0-8248-a440d8a444ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shefabone™
• Version Model Number: SCPC Granules
• Catalog Number: SCPC-1
• Company DUNS: 080521608
• Company Name: SHEFABONE 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

Customer Support Contacts

• Phone: 7044971716
• Email: arelgha@shefabone.com

Device Dimensions

• Total Volume: 1 Centiliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060517850005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153230

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

[05060517850005]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-18