Home GUDID 00810168190129 NA
Primary DI 00810168190129
Brand NA
Company PACIFIC INSTRUMENTS, INC.
Model PI-3797
Device description Scalpel Handle, 8 Inch
Published 2025-06-25
Public version status Update
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 00810168190129 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 00810168190129 00810168190129 810168190129 0810168190129
GMDN Terms# Term, Definition table Term Definition Surgical instrument handle, non-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, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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