GUIDOR C11-018

GUDID 17640164360123

Bone grafting material, synthetic

SUNSTAR AMERICAS, INC.

Dental bone matrix implant, synthetic

• Primary Device ID: 17640164360123
• NIH Device Record Key: 973ed8d7-3691-41f3-b71a-6fd9a6294e13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUIDOR
• Version Model Number: easy-graft CLASSIC
• Catalog Number: C11-018
• Company DUNS: 025066358
• Company Name: SUNSTAR AMERICAS, 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: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx
• Phone: 8002658353
• Email: xx@xx.xx

Device Dimensions

• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter
• Total Volume: 0.15 Milliliter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640164360089 [Primary]
GS1	17640164360123 [Package]; Contains: 07640164360089; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131385

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

On-Brand Devices [GUIDOR]

• 00070942000079: GUIDOR® Bioresorbable Matrix Barrier
• 00070942000062: GUIDOR® Bioresorbable Matrix Barrier
• 00070942000055: GUIDOR® Bioresorbable Matrix Barrier
• 00070942000048: GUIDOR® Bioresorbable Matrix Barrier
• 00070942000031: GUIDOR® Bioresorbable Matrix Barrier
• 00070942000017: GUIDOR® Bioresorbable Matrix Barrier
• 07640164360140: Bone grafting material, synthetic
• 17640164360130: Bone grafting material, synthetic
• 17640164360123: Bone grafting material, synthetic
• 17640164360116: Bone grafting material, synthetic