AVID TruCustom

Basic Information

• Brand Name: AVID TruCustom
• Primary DI: 10809160075845
• Version / Model: BAHA004-06_0005
• Company Name: AVID MEDICAL, INC.
• Labeler DUNS: 015623119
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 4
• Public Version Date: 2023-08-08
• Public Version Status: Update
• Public Device Record Key: 0af44e09-65f8-46a8-9573-ba0d952e177b
• Distribution End Date: 2023-08-08

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
OGD	Custom anesthesia tray	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34842	Epidural anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160075842	GS1		10	Not in Commercial Distribution	2023-08-08
Primary	10809160075845	GS1