AVID TruCustom

Basic Information

• Brand Name: AVID TruCustom
• Primary DI: 10809160108604
• Version / Model: RDVA007-01_0002
• Company Name: AVID MEDICAL, INC.
• Labeler DUNS: 015623119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a9ddc10b-d180-4732-91d4-0904079353e4

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
LRO	General surgery tray	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61645	Hand-held electrosurgical system	A sterile, hand-held, battery-powered device intended to generate radio-frequency (RF) electrical energy to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulation during open and laparoscopic surgical procedures of multiple clinical specialties (i.e., non-dedicated). It is a handpiece which includes the energy-producing generator, controls, with fixed bipolar electrodes at the distal end of a shaft, which apply the energy to the surgical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160108601	GS1		3	In Commercial Distribution
Primary	10809160108604	GS1