AccessGUDID - DEVICE: TRUFILL (10886704029151)

GUDID

Device Identifier (DI) Information

Brand Name: TRUFILL
Version or Model: 631-500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 631500
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704029151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: Contents:one 1 g tube n-BCA with self-piercing luer cap one 1 g vial Ta Powder one 10 mL vial Ethiodized Oil

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KGG	tissue adhesive for use in embolization of brain arteriovenous malformations

FDA Premarket Submission

FDA Premarket 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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1affe4b-e728-427f-9544-294d7af8e7e1
Public Version Date: February 27, 2025
Public Version Number: 5
DI Record Publish Date: September 20, 2014