Tungst.Carb.Burr,Ø3.5x70mm,50k

Basic Information

• Brand Name: Tungst.Carb.Burr,Ø3.5x70mm,50k
• Primary DI: 07630055506757
• Version / Model: 340835
• Catalog Number: 1100534-001
• Company Name: Bien-Air Surgery SA
• Labeler DUNS: 481597719
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-22
• Public Version: 1
• Public Version Date: 2023-03-02
• Public Version Status: New
• Public Device Record Key: 43901c20-20a3-45b5-855c-449b9d0d6da2

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: Yes
• 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
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	874.4140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46391	Metal/carbide ENT bur, reusable	A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17630055506754	GS1		1	In Commercial Distribution
Primary	07630055506757	GS1