Bur PM2-95 80K diamond Ø2.3mm sterile

Basic Information

• Brand Name: Bur PM2-95 80K diamond Ø2.3mm sterile
• Primary DI: J00711003220011
• Version / Model: 1100322
• Catalog Number: 1100322-001
• Company Name: Bien-Air Surgery SA
• Labeler DUNS: 481597719
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-08
• Public Version: 3
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 871f026d-673c-445b-827b-a6a3838a08f4
• Distribution End Date: 2023-02-03

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
45527	Diamond ENT bur, single-use	A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00711003220011	HIBCC