Home GUDID 00810168190136 NA
Primary DI 00810168190136
Brand NA
Company PACIFIC INSTRUMENTS, INC.
Model PI-3451
Device description Nonparallel Distractor for up to 6.0mm Rod
Published 2025-07-10
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 00810168190136 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 00810168190136 00810168190136 810168190136 0810168190136
GMDN Terms# Term, Definition table Term Definition Orthopaedic surgical distractor, internal A hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 621872006 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