TRUFILL 632400NA

GUDID 10886704085324

TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: (2) 1 g n-BCA, self-piercing caps, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels

Cerenovus, Inc.

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

• Primary Device ID: 10886704085324
• NIH Device Record Key: d4f0b9d2-dcb1-4a18-be0e-afbb870ae0f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUFILL
• Version Model Number: 632400NA
• Catalog Number: 632400NA
• Company DUNS: 607846297
• Company Name: Cerenovus, 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: +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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704085324 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [TRUFILL]

• 10886704085324: TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: (2) 1 g n-BCA, self-piercing caps,
• 10886704085317: TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: 1 g n-BCA, self-piercing cap, 1 g T