Diamond Burr

Basic Information

• Brand Name: Diamond Burr
• Primary DI: 00846338004125
• Version / Model: 16-0218
• Company Name: ELLIQUENCE, LLC
• Labeler DUNS: 019872358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-07
• Public Version: 1
• Public Version Date: 2025-01-15
• Public Version Status: New
• Public Device Record Key: 77695163-f0b7-42ec-ac05-1ec92a916d66

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60819	Spinal decompression cutting handpiece/endpiece	A sterile, hand-held, powered surgical instrument designed to excise spinal (central canal and foramen) soft and hard tissue to relieve pressure (decompression) on adjacent nerve tissue, especially in the case of spinal stenosis or degenerative disk disease (DDD). It typically consists of a handpiece and integral metal (e.g., stainless steel) shaft, which may have a straight or curved tip, terminating in an exposed or shielded rotary cutting burr. The rotary action is provided by a suitable electrically or pneumatically-powered motor attached to the proximal end of the handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846338004125	GS1