Device
Articulating Diamond Burr, One (1) Sterile, Single Use, D: 3.7mm
Manufacturer
ELLIQUENCE, LLC
ELLIQUENCE, LLC
Model: 16-0201
DI: 00846338003876
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Articulating Diamond Burr, One (1) Sterile, Single Use, D: 3.7mm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
07f54dcd-1425-4003-9b69-68729a9af595
Distribution Status:
In Commercial Distribution
DUNS Number:
019872358
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00846338003876
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60819
Name: Spinal decompression cutting handpiece/endpiece
Definition:
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.
FDA Product Codes
GEY
Motor, Surgical Instrument, Ac-Powered