TRUFILL 635002

GUDID 10886704029410

TRUFILL DCS Syringe II

Medos International Sàrl

Embolization implant syringe Embolization implant syringe Embolization implant syringe Embolization implant syringe Embolization implant syringe Embolization implant syringe Embolization implant syringe Embolization implant syringe Embolization implant syringe Embolization implant syringe

• Primary Device ID: 10886704029410
• NIH Device Record Key: 47bfa502-5d77-40fc-ac03-3274a545aaf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUFILL
• Version Model Number: 635-002
• Catalog Number: 635002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704029410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063254

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR EMBOLIZATION

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: 2020-01-31
• Device Publish Date: 2015-09-20

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