Device
Dilator OD: 5.3mm ID: 1.8mm WL: 230mm
Manufacturer
ELLIQUENCE, LLC
Model: 11-2330 DI: 00846338007232 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
Dilator OD: 5.3mm ID: 1.8mm WL: 230mm
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: be8256b1-d9ff-406e-bd43-24113590a81b
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: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00846338007232
Type: Primary
Issuing Agency: GS1
GMDN
Code: 32579
Name: Spinal endoscopic-access system
Definition:
An assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.
FDA Product Codes
MDM
Instrument, Manual, Surgical, General Use