Home GUDID 05397283000236 Pro-X1
Primary DI 05397283000236
Brand Pro-X1
Company X-BOLT ORTHOPEDICS INC.
Model XNI-025
Device description Stealth Palm Screwdriver Handle
Published 2024-08-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HSB Rod, Fixation, Intramedullary And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSB Rod, Fixation, Intramedullary And Accessories Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05397283000236 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05397283000236 05397283000236 5397283000236
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 119116284 Device count 1 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 B058AHN08165L1 Atlas™ Humeral Nail System Orthopedic Designs North America, Inc. HSB 2026-05-29 B058AHN08165R1 Atlas™ Humeral Nail System Orthopedic Designs North America, Inc. HSB 2026-05-29 10855068008423 Lock Activator CURVAFIX, INC. HSB 2022-06-20 10855068008492 Inserter/Extractor CURVAFIX, INC. HSB 2022-06-20 10855068008539 Sterilization Case, Outer CURVAFIX, INC. HSB 2022-06-20 10855068008621 Ring Lock, Long Inserter CURVAFIX, INC. HSB 2022-06-20 10855068008003 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008010 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008027 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008034 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008041 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008058 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008065 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008072 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008089 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008096 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 10855068008102 CurvaFix® IM Implant CURVAFIX, INC. HSB 2021-08-11 07898624869669 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-21 07898624869140 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869157 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869164 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869171 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869188 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869195 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869201 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869218 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869225 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869232 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869249 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06 07898624869256 NEONAIL Neoortho Produtos Ortopédicos S/A. HSB 2015-10-06