Gibson Healthcare Alloplast 6248-008

GUDID 17640164360031

Synthetic Bone Graft System

Degradable Solutions AG

Dental bone matrix implant, synthetic

• Primary Device ID: 17640164360031
• NIH Device Record Key: 9057fb9e-581f-41b3-a319-27791bca0733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gibson Healthcare Alloplast
• Version Model Number: 6248-008
• Catalog Number: 6248-008
• Company DUNS: 482821667
• Company Name: Degradable Solutions AG
• 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: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com
• Phone: 1-570-602-6924
• Email: DL.Regulatory.Affairs@Benco.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640164360041 [Primary]
GS1	17640164360031 [Package]; Contains: 07640164360041; Package: Box [3 Units]; In Commercial Distribution

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-13
• Device Publish Date: 2024-03-05

On-Brand Devices [Gibson Healthcare Alloplast]

• 17640164360055: Synthetic Bone Graft System
• 17640164360031: Synthetic Bone Graft System
• 07640164360027: Synthetic Bone Graft System