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 00763000880118 MSB Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-10-23 00842528130056 OSTEOMED OSTEOMED LLC LXH 2026-10-23 00888867550391 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550407 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550414 Arthrex® ARTHREX, INC. LXH 2026-10-23 00888867550421 Arthrex® ARTHREX, INC. LXH 2026-10-23 04251631412144 BEE PLIF NGMedical GmbH LXH 2026-10-23 M739153997700 Cross Connector Driver CAPTIVA SPINE, INC. LXH 2026-10-23 M739153998800 Cross Connector Counter Torque CAPTIVA SPINE, INC. LXH 2026-10-23 M739243501000 Blade Dilator CAPTIVA SPINE, INC. LXH 2026-10-23 M739243502000 Parallel Guide CAPTIVA SPINE, INC. LXH 2026-10-23 M739243503000 In-Line Handle CAPTIVA SPINE, INC. LXH 2026-10-23 M739243504000 Tissue Dilator CAPTIVA SPINE, INC. LXH 2026-10-23 M739243505000 Tissue Protector CAPTIVA SPINE, INC. LXH 2026-10-23 M739243506000 Adjustable Parallel Guide CAPTIVA SPINE, INC. LXH 2026-10-23 M739243507000 Impaction Sleeve CAPTIVA SPINE, INC. LXH 2026-10-23 M739243508000 Self-Feeding Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739243509000 Implant Filling Tube CAPTIVA SPINE, INC. LXH 2026-10-23 M739243511000 Plunger Rod CAPTIVA SPINE, INC. LXH 2026-10-23 M739243512000 Cannulated Drill, 7mm CAPTIVA SPINE, INC. LXH 2026-10-23 M739983015106 6mm Cannulated Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739983015107 7mm Cannulated Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739983015108 8mm Cannulated Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739983015109 9mm Cannulated Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739983015110 10mm Cannulated Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739983015111 11mm Cannulated Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739983015112 12mm Cannulated Drill CAPTIVA SPINE, INC. LXH 2026-10-23 M739983101200 Coupling - Square Connect CAPTIVA SPINE, INC. LXH 2026-10-23 M739983240300 Impaction T-Handle CAPTIVA SPINE, INC. LXH 2026-10-23 M739985202530 Marking Pin CAPTIVA SPINE, INC. LXH 2026-10-23