Home GUDID 00840194495806 3P Small-Mini Frag System
Primary DI 00840194495806
Brand 3P Small-Mini Frag System
Company ORTHOPEDIATRICS CORP.
Model 01-3100-1016
Catalog number 01-3100-1016
Device description 2.0 Torque Limiter Coupling, AO, 0.4Nm
Published 2026-06-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KIJ Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment LXH Orthopedic manual surgical instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery 1 LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840194495806 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840194495806 00840194495806 840194495806 0840194495806
GMDN Terms# Term, Definition table Term Definition Surgical instrument handle, torque-limiting A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. 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 796416191 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00824846013082 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-10-19 00850078396440 SYNQ Single-Use Instrument System(1066) Eca Medical Instruments LXH 2026-10-19 00889024715295 Persona Extended V/V Guide Assembly (MFS) Zimmer, Inc. LXH 2026-10-19 08809986489807 LnK Spinal Instrument System L&K BIOMED CO. ,LTD. LXH 2026-10-19 00810111228671 Cut Guide Treace Medical Concepts, Inc. LXH 2026-10-16 00810161900305 EARP, TRIAL 22X35X12 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161900312 EARP, TRIAL 22X35X14 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161900329 EARP, TRIAL 22X35X12 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161900336 EARP, TRIAL 22X35X14 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901418 EARP TRIAL 22x40x10 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901425 EARP TRIAL 22x40x12 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901432 EARP TRIAL 22x40x14 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901449 EARP TRIAL 22x40x12 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901456 EARP TRIAL 22x40x14 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901463 EARP TRIAL 22x45x10 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901470 EARP TRIAL 22x45x12 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901487 EARP TRIAL 22x45x14 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901494 EARP TRIAL 22x45x12 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901500 EARP TRIAL 22x45x14 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901692 EARP TRIAL 22x50x10 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901708 EARP TRIAL 22x50x12 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901715 EARP TRIAL 22x50x14 6° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901722 EARP TRIAL 22x50x12 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00810161901739 EARP TRIAL 22x50x14 12° RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-16 00840606197007 MERCURY SPINAL ELEMENTS, INC. LXH 2026-10-16 00840606197014 MERCURY SPINAL ELEMENTS, INC. LXH 2026-10-16 00840606197021 MERCURY SPINAL ELEMENTS, INC. LXH 2026-10-16 00840606197038 MERCURY SPINAL ELEMENTS, INC. LXH 2026-10-16 05055662922622 Volition™ Plating System ORTHO SOLUTIONS HOLDINGS LIMITED LXH 2026-10-16 00810161900015 EARP DISC SPACER INSERTER RETROPSOAS TECHNOLOGIES, LLC LXH 2026-10-15
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