AVID TruCustom

Basic Information

• Brand Name: AVID TruCustom
• Primary DI: 10809160088050
• Version / Model: ADVC024-22_0002
• Catalog Number: ADVC024-22
• Company Name: AVID MEDICAL, INC.
• Labeler DUNS: 015623119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 3
• Public Version Date: 2018-09-14
• Public Version Status: Update
• Public Device Record Key: 0e3eec20-9bb9-4f52-8541-dd7974ed7007

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJG	Neurological tray	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44064	Neurosurgical procedure kit, medicated	A collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160088057	GS1		4	In Commercial Distribution
Primary	10809160088050	GS1

Customer Contacts

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