Home GUDID B16790042144T0 CURE OPEL-L
Primary DI B16790042144T0
Brand CURE OPEL-L
Company MEDITECH SPINE, LLC
Model 900-421-44-T
Published 2022-10-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KWQ Appliance, fixation, spinal intervertebral body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B16790042144T0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition General internal orthopaedic fixation system implantation kit A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 182698477 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00643169465879 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWQ 2026-06-28 00810017913893 Saber-C Body (PT), 14x17x6 6 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017913909 Saber-C Body (PT), 14x17x7 6 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017913916 Saber-C Body (PT), 14x17x8 6 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017913923 Saber-C Body (PT), 14x17x9 6 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017914357 Saber-C Plate, 12x15x5 12 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017914364 Saber-C Plate, 12x15x6 12 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017914371 Saber-C Plate, 12x15x7 12 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017914388 Saber-C Plate, 12x15x8 12 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017914395 Saber-C Plate, 12x15x9 12 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017914401 Saber-C Plate, 12x15x10 12 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 00810017914630 Saber-C Plate, 14x17x9 12 deg. ELEVATION SPINE, INC. KWQ 2026-06-25 10889981142117 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142124 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142148 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142155 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142179 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142186 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142193 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142209 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142216 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142223 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142230 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142247 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142254 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142261 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142278 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142285 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981142292 Mariner Seaspine Orthopedics Corporation KWQ 2021-10-02 10889981182717 Mariner Seaspine Orthopedics Corporation KWQ 2019-10-24