TRUFILL

Basic Information

• Brand Name: TRUFILL
• Primary DI: 10886704029151
• Version / Model: 631-500
• Catalog Number: 631500
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: e1affe4b-e728-427f-9544-294d7af8e7e1

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGG	tissue adhesive for use in embolization of brain arteriovenous malformations	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60939	Neurovascular embolization plug	A non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704029151	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P990040	001
P990040	002
P990040	003
P990040	004
P990040	005
P990040	006
P990040	007
P990040	008
P990040	009
P990040	010
P990040	011
P990040	012
P990040	013
P990040	014
P990040	015
P990040	016
P990040	017
P990040	019
P990040	020
P990040	021
P990040	022
P990040	023
P990040	024

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if opened or damaged.
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dark, dry place.