AVID TruCustom

Basic Information

• Brand Name: AVID TruCustom
• Primary DI: 10809160036679
• Version / Model: YNHN044-01_0001
• Company Name: AVID MEDICAL, INC.
• Labeler DUNS: 015623119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: 13988784-efb9-4085-ac69-8c343f09dc1d

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
47933	Skin allograft	Skin tissue intended for transplantation that is harvested from a human donor genetically different from the human recipient. The implanted tissue is intended to repair, replace, or reinforce skin affected by extensive wounds, burns, and soft tissue defects and typically helps to protect against infection, reduce pain, reduce fluid loss, and/or allows the native tissues underneath to heal. It is typically cryopreserved cadaver skin from a skin bank which may have been subjected to various degrees of processing (e.g., epidermis removal, decellularized dermis, glycerolization, sterilization). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160036676	GS1		10	In Commercial Distribution
Primary	10809160036679	GS1