Home GUDID 08809489295059 Huvex
Primary DI 08809489295059
Brand Huvex
Company DIOMEDICAL CO.,LTD.
Model A
Catalog number SO.IN.0031
Device description I-Handle
Published 2017-11-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
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 08809489295059 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809489295059 08809489295059 8809489295059
GMDN Terms# Term, Definition table Term Definition Lumbar interspinous decompression spacer, non-sterile A non-sterile device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. This is a single-use device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 557795909 Device count 1 DM exempt true Lot or batch true Manufacturing date on label 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
huvexel.com