Home GUDID 08800015919135 Benefix™ Interspinous Fixation System
Primary DI 08800015919135
Brand Benefix™ Interspinous Fixation System
Company CG MedTech Co.,Ltd.
Model IS20838R
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PEK Spinous process plate
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PEK Spinous Process Plate Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800015919135 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800015919135 08800015919135 8800015919135
GMDN Terms# Term, Definition table Term Definition Interspinous spinal fixation implant An implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool dry place.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688811082 Device count 1 DM exempt true Lot or batch true Serial number 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 M9431002200000 Minuteman Spinal Simplicity, LLC PEK 2026-02-23 M9431002210000 Minuteman Spinal Simplicity, LLC PEK 2026-02-23 M9431002220000 Minuteman Spinal Simplicity, LLC PEK 2026-02-23 M9431002230000 Minuteman Spinal Simplicity, LLC PEK 2026-02-23 M9431002240000 Minuteman Spinal Simplicity, LLC PEK 2026-02-23 10889981146498 General Seaspine Orthopedics Corporation PEK 2025-12-19 07640185341678 ROMEO 2 PAD INSTRUMENTATION SpineArt SA PEK 2025-11-11 B1830712181100 KeyLift™ FLOSPINE LLC PEK 2025-02-03 B1830712181120 KeyLift™ FLOSPINE LLC PEK 2025-02-03 B1830712181140 KeyLift™ FLOSPINE LLC PEK 2025-02-03 B1830712181160 KeyLift™ FLOSPINE LLC PEK 2025-02-03 B1830712200100 KeyLift™ FLOSPINE LLC PEK 2025-02-03 B1830712200120 KeyLift™ FLOSPINE LLC PEK 2025-02-03 B1830712200140 KeyLift™ FLOSPINE LLC PEK 2025-02-03 B1830712200160 KeyLift™ FLOSPINE LLC PEK 2025-02-03 10889981146412 NewPort Seaspine Orthopedics Corporation PEK 2024-12-11 10889981146436 NewPort Seaspine Orthopedics Corporation PEK 2024-12-11 10889981146443 NewPort Seaspine Orthopedics Corporation PEK 2024-12-11 10889981146450 NewPort Seaspine Orthopedics Corporation PEK 2024-12-11 10889981146467 NewPort Seaspine Orthopedics Corporation PEK 2024-12-11 10889981146474 NewPort Seaspine Orthopedics Corporation PEK 2024-12-11 10889981146481 NewPort Seaspine Orthopedics Corporation PEK 2024-12-11 10889981096298 General Seaspine Orthopedics Corporation PEK 2024-06-11 10889981096304 General Seaspine Orthopedics Corporation PEK 2024-06-11 10889981096311 General Seaspine Orthopedics Corporation PEK 2024-06-11 00190837137090 Aileron TRX Life Spine, Inc. PEK 2022-07-11 M9431001040000 Minuteman G5 Spinal Simplicity, LLC PEK 2022-05-13 M9431001000000 Minuteman G5 Spinal Simplicity, LLC PEK 2022-05-13 M9431001010000 Minuteman G5 Spinal Simplicity, LLC PEK 2022-05-13 M9431001020000 Minuteman G5 Spinal Simplicity, LLC PEK 2022-05-13