GUIDOR easy-graft CLASSIC C11-078

GUDID 07640164361819

in situ hardening synthetic bone graft system, 0.25 Milliliter

Degradable Solutions AG

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• Primary Device ID: 07640164361819
• NIH Device Record Key: 6a5f14c7-3987-4603-ac84-3fbeb4cb7f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUIDOR easy-graft CLASSIC
• Version Model Number: C11-078
• Catalog Number: C11-078
• 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

Device Dimensions

• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640164360096 [Previous]
GS1	07640164361819 [Primary]
GS1	17640164363193 [Package]; Package: [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: 2022-05-10
• Device Publish Date: 2022-05-02

On-Brand Devices [GUIDOR easy-graft CLASSIC]

• 07640164364544: in situ hardening synthetic bone graft system, 0.15 Milliliter
• 07640164361819: in situ hardening synthetic bone graft system, 0.25 Milliliter
• 07640164360645: in situ hardening synthetic bone graft system, 0.4 Milliliter