Home GUDID 05397283000045 Pro-X1
Primary DI 05397283000045
Brand Pro-X1
Company X-BOLT ORTHOPEDICS INC.
Model XNI-004
Device description Outer Proximal Reamer Sleeve
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 05397283000045 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05397283000045 05397283000045 5397283000045
GMDN Terms# Term, Definition table Term Definition Orthopaedic implantation sleeve, reusable A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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