Home GUDID 05391529583071
Apex
Primary DI 05391529583071
Brand Apex
Company ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model INS-1128
Catalog number INS-1128
Device description Locking Screw Length Gauge (Hook)
Published 2021-01-29
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 HTJ Gauge, Depth
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTJ Gauge, Depth Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391529583071 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391529583071 05391529583071 5391529583071
GMDN Terms# Term, Definition table Term Definition Surgical depth gauge, reusable A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Ambient Storage and Handling
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 985596830 Device count 1 DM exempt true Premarket exempt true 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 08809513720045 SAEHAN Hydraulic Pinch Gauge Saehan Corporation HTJ 2026-05-18 08809513720359 SAEHAN Mechanical Pinch Gauge Saehan Corporation HTJ 2026-05-18 10850070500484 Cannulated Depth Guage CURVAFIX, INC. HTJ 2025-10-22 08800071006862 Surgical Instrument OSTEONIC CO.,Ltd. HTJ 2025-06-24 08809539690667 Surgical Instrument OSTEONIC CO.,Ltd. HTJ 2025-06-24 10840199512703 Depth Gauge KOROS U.S.A., INC. HTJ 2024-12-31 10840199513670 Multi Level Black Belt Depth Gauge KOROS U.S.A., INC. HTJ 2024-12-31 10885862573483 EPIC Exactech, Inc. HTJ 2024-01-08 07708604560472 SAMPEDRO INDUSTRIAS MEDICAS SAMPEDRO S A S HTJ 2023-01-18 08055727374561 DEPTH GAUGE 9 mm HPF SRL HTJ 2022-12-09 08055727374578 DEPTH GAUGE 9 mm HPF SRL HTJ 2022-12-09 10603295550273 INHANCE DEPUY (IRELAND) HTJ 2022-12-09 10855068008607 Implant Selection Device CURVAFIX, INC. HTJ 2022-12-05 10855068008331 Implant Selection Device CURVAFIX, INC. HTJ 2021-12-02 08800089415298 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089415328 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089417230 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089418350 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089418374 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089402762 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2021-05-28 08800089402779 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2021-05-28 08800089402830 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2021-05-28 M684E15000401 EVOLUTION Microport Orthopedics Inc. HTJ 2019-12-23 08806390873765 VERUM System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-17 08806390863247 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-05 08806390865869 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-05 08806390867764 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-05 08806390857963 VERUM System Surgical Instrument Jeil Medical Corporation HTJ 2018-11-28 08806390859219 VERUM System Surgical Instrument Jeil Medical Corporation HTJ 2018-11-28 08806390860031 VERUM System Surgical Instrument Jeil Medical Corporation HTJ 2018-11-28