Home GUDID M743120014 OptiMesh Multiplanar Expandable Interbody Fusion System
Primary DI M743120014
Brand OptiMesh Multiplanar Expandable Interbody Fusion System
Company SPINEOLOGY INC.
Model 33-08-02
Catalog number 312-0014
Device description Dilator One
Published 2023-09-14
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M743120014 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Laparoscopic access cannula dilator A hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in minimally-invasive laparoscopic procedures. The dilator is entered over a guide rod, forcing a larger opening as the skin is pressed aside, thereby reducing the possible degree of damage. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 033014361 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M7403030001 Discectomy Set 10-01-138 303-0001 2026-07-08 M7403030002 Discectomy Set 10-01-139 303-0002 2026-07-08 M7403030069 Discectomy Set 15-01-58 303-0069 2026-07-08 M7403030070 Discectomy Set 15-01-59 303-0070 2026-07-08 M7403030071 Discectomy Set 15-01-60 303-0071 2026-07-08 M7404300035 CAPTURE Facet Screw Set System 70-02-008-1 430-0035 2026-05-29 M7403030028 Discectomy Set 15-01-45-1 303-0028 2026-05-28 M7403030029 Discectomy Set 15-01-45-2 303-0029 2026-05-28 M7403030030 Discectomy Set 15-01-45-3 303-0030 2026-05-28 M7403030031 Discectomy Set 15-01-45-4 303-0031 2026-05-28 M7403030032 Discectomy Set 15-01-45-5 303-0032 2026-05-28 M7403030033 Discectomy Set 15-01-45-6 303-0033 2026-05-28 M7403030034 Discectomy Set 15-01-45-7 303-0034 2026-05-28 M7403030035 Discectomy Set 15-01-45-8 303-0035 2026-05-28 M7403030036 Discectomy Set 15-01-45-9 303-0036 2026-05-28 M7403030059 Discectomy Set 15-01-45-10 303-0059 2026-05-28 M7403030060 Discectomy Set 15-01-45-11 303-0060 2026-05-28 M7401001373 MIS TLIF System 102-86-01 100-1373 2026-05-21 M7401001371 OptiLIF Endo, Direct Visualization System 102-84-01 100-1371 2026-04-06 M7406410015 Fortress Pedicular Fixation 64-02-01 641-0015 2024-01-10
Other Devices Sharing Product Codes# 
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