Guided Tray

Basic Information

• Brand Name: Guided Tray
• Primary DI: 00813110024855
• Version / Model: 260-104-960
• Catalog Number: 260-104-960
• Company Name: BICON, LLC
• Labeler DUNS: 945015758
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-10
• Public Version: 4
• Public Version Date: 2020-01-09
• Public Version Status: Update
• Public Device Record Key: 1b13b4b4-0ce9-41c8-b253-08d6a517852f
• Distribution End Date: 2019-09-16

Device Description

6.0mm Guided Surgical Tray

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45714	Fixture/appliance dental drill bit, reusable	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813110024855	GS1

Customer Contacts

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