HS Craniotome Burr, long 80k

Basic Information

• Brand Name: HS Craniotome Burr, long 80k
• Primary DI: 17630055507485
• Version / Model: 362640 L
• Catalog Number: 1100607-001
• 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: 04a80a81-b337-4841-81f5-d32069cb8078

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HBC	Motor, Drill, Electric	Neurology	882.4360	2
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	882.4310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46269	Cranial bur, single-use	A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27630055507482	GS1	Box	1	In Commercial Distribution
Primary	17630055507485	GS1

Premarket Submissions

Submission Number	Supplement Number
K173066	000