Home GUDID 08800071017073 Signex
Primary DI 08800071017073
Brand Signex
Company OSTEONIC CO.,Ltd.
Model Y7D.15010
Published 2025-06-27
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 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 08800071017073 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800071017073 08800071017073 8800071017073
GMDN Terms# Term, Definition table Term Definition Surgical instrument torque limiter A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688999370 Device count 1 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 00840286860093 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860109 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 00840286860116 Tahoe Unicompartmental Knee System Shalby Advanced Technologies, Inc. LXH 2026-07-09 10705034647463 N/A Medos International Sàrl LXH 2026-07-09 B382SD49400B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49401B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49402B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49403B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49404B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49405B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49406B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49407B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49408B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49409B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49410B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49411B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49412B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49413B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49414B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49415B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49416B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49417B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49418B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49419B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD49420B0 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500010 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500020 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500030 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500040 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09 B382SD500050 Surgical Direct Surgical Direct, Inc. LXH 2026-07-09