TRUFILL 631400

GUDID 10886704029144

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

Medos International Sàrl

Neurovascular embolization plug

• Primary Device ID: 10886704029144
• NIH Device Record Key: b9da3511-00b0-4022-81cc-9bcf270aa1e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUFILL
• Version Model Number: 631-400
• Catalog Number: 631400
• 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
• 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
• 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 *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.
• 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.
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704029144 [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