AVID TruCustom

Basic Information

• Brand Name: AVID TruCustom
• Primary DI: 10809160176238
• Version / Model: LIFP031_0004
• Company Name: AVID MEDICAL, INC.
• Labeler DUNS: 015623119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-12
• Public Version: 4
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 80ad8ad8-957c-4902-822c-d03c2c1992bf

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
LYV	LABEL OR TAG, STERILE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62002	Laboratory specimen/material barcode label	A label (e.g., a card or insert) featuring a barcode intended to facilitate clear and easy identification of a laboratory specimen and/or material (e.g., a clinical specimen or assay reagent/buffer in a container). It is electronically readable using a computerized reader or scanner, either on-board or connected to an instrument or analyser. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160176235	GS1		10	In Commercial Distribution
Primary	10809160176238	GS1