Home GUDID B058ODIF161 Cortical Drill
Primary DI B058ODIF161
Brand Cortical Drill
Company Orthopedic Designs North America, Inc.
Model ODIF16
Catalog number ODI-F16
Device description Cortical Drill, 4.2mm
Published 2023-06-23
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 HTW Bit, Drill
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTW Bit, Drill Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B058ODIF161 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Fluted surgical drill bit, reusable A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 945518848 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B058AHN5026NS1 Atlas™ Humeral Nail System AHN5026NS AHN-5-026NS 2026-05-04 B058AHN5028NS1 Atlas™ Humeral Nail System AHN5028NS AHN-5-028NS 2026-05-04 B058AHN5030NS1 Atlas™ Humeral Nail System AHN5030NS AHN-5-030NS 2026-05-04 B058AHN5032NS1 Atlas™ Humeral Nail System AHN5032NS AHN-5-032NS 2026-05-04 B058AHN11C00L1 Atlas™ Humeral Nail System AHN11C00L AHN-11-C00-L 2025-01-28 B058AHN11C05L1 Atlas™ Humeral Nail System AHN11C05L AHN-11-C05-L 2025-01-28 B058AHN11C10L1 Atlas™ Humeral Nail System AHN11C10L AHN-11-C10-L 2025-01-28 B058ART13C001 ART End Cap ART13C00 ART-13-C00 2021-11-29 B058ART13C051 ART End Cap ART13C05 ART-13-C05 2021-11-29 B058ART13C101 ART End Cap ART13C10 ART-13-C10 2021-11-29 B058ART13C151 ART End Cap ART13C15 ART-13-C15 2021-11-29 B058HTN10C011 Talon™ DistalFix™ HTN End Cap HTN10C01 HTN-10-C01 2018-03-16 B058HTN10C01L1 Talon™ DistalFix™ HTN End Cap Locking HTN10C01L HTN-10-C01-L 2019-03-07 B058HTN10C051 Talon™ DistalFix™ HTN End Cap HTN10C05 HTN-10-C05 2018-03-16 B058HTN10C05L1 Talon™ DistalFix™ HTN End Cap Locking HTN10C05L HTN-10-C05-L 2019-03-07 B058HTN10C101 Talon™ DistalFix™ HTN End Cap HTN10C10 HTN-10-C10 2018-03-16 B058HTN10C10L1 Talon™ DistalFix™ HTN End Cap Locking HTN10C10L HTN-10-C10-L 2019-03-07 B058HTN10C151 Talon™ DistalFix™ HTN End Cap HTN10C15 HTN-10-C15 2018-03-16 B058HTN10C15L1 Talon™ DistalFix™ HTN End Cap Locking HTN10C15L HTN-10-C15-L 2019-03-07 B058SLN1550001 Talon™ DistalFix™ End Cap SLN155000 2015-10-19
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