Home GUDID 00810166521659 X-PAC
Primary DI 00810166521659
Brand X-PAC
Company EXPANDING INNOVATIONS, INC.
Model EI2617
Device description X-PAC TLIF Expandable Trial Torque Handle
Published 2026-05-01
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 00810166521659 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 00810166521659 00810166521659 810166521659 0810166521659
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 081309444 Device count 1 Premarket exempt true Kit 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
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