TRUFILL 631500

GUDID 10886704029151

n-Butyl Cyanoacrylate n-BCA Liquid Embolic System one 1g unit n-BCA one 1g unit Ta Powder one 10mL vial of Ethiodized Oil

Medos International Sàrl

Neurovascular embolization plug Neurovascular embolization plug Neurovascular embolization plug Neurovascular embolization plug Neurovascular embolization plug Neurovascular embolization plug Neurovascular embolization plug Neurovascular embolization plug Neurovascular embolization plug

• Primary Device ID: 10886704029151
• NIH Device Record Key: e1affe4b-e728-427f-9544-294d7af8e7e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUFILL
• Version Model Number: 631-500
• Catalog Number: 631500
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704029151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990040

FDA Product Code

• KGG: tissue adhesive for use in embolization of brain arteriovenous malformations

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-09-20

On-Brand Devices [TRUFILL]

• 10886704029410: TRUFILL DCS Syringe II
• 10886704029151: n-Butyl Cyanoacrylate n-BCA Liquid Embolic System one 1g unit n-BCA one 1g unit Ta Powder one 10
• 10886704029144: n-Butyl Cyanoacrylate n-BCA Liquid Embolic System two 1g units n-BCA one 1g unit Ta Powder one 1