AVID TruCustom

Basic Information

• Brand Name: AVID TruCustom
• Primary DI: 10809160242001
• Version / Model: KLRH012-03_0020
• Catalog Number: KLRH012-03
• Company Name: AVID MEDICAL, INC.
• Labeler DUNS: 015623119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-05
• Public Version: 2
• Public Version Date: 2023-01-30
• Public Version Status: Update
• Public Device Record Key: ec57f0e0-3d01-4bba-9591-344f9b1bfb1c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRO	General surgery tray	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44068	ENT surgical procedure kit, medicated	A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform an ENT surgical 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	20809160242008	GS1		3	In Commercial Distribution
Primary	10809160242001	GS1

Customer Contacts

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