Drill Bit

Basic Information

• Brand Name: Drill Bit
• Primary DI: G2843520100
• Version / Model: 352-01-00
• Company Name: Neurovention LLC
• Labeler DUNS: 074912476
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-17
• Public Version: 1
• Public Version Date: 2024-10-25
• Public Version Status: New
• Public Device Record Key: 80ae1200-038f-4c74-8709-b70b9f49d301
• Distribution End Date: 2024-10-17

Device Description

Drill Bit 1.7 mm, Single-Use

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	882.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43390	Fluted surgical drill bit, single-use	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G2843520100	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K192162	000