Home GUDID B068DB07851 Simpex Drill Bit
Primary DI B068DB07851
Brand Simpex Drill Bit
Company SIMPEX MEDICAL, INC.
Model DB-078-5
Catalog number DB-078-5
Device description "Twist Drill Bit .078"" DIA x 5"" LG"
Published 2019-10-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use 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 B068DB07851 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Fluted surgical drill bit, single-use, non-sterile A non-sterile 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, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 2 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 932637023 Device count 1 Premarket exempt true Lot or batch true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B068B125121 Simpex Steinmann Pin B-125-12 B-125-12 2016-09-26 B068D0781 Simpex Steinmann Pin D-078 D-078 2015-09-23 B068D078121 Simpex Steinmann Pin D-078-12 D-078-12 2015-09-23 B068D07812S1 Simpex Steinmann Pin D-078-12S D-078-12S 2015-09-23 B068D078S1 Simpex Steinmann Pin D-078-S D-078-S 2015-09-23 B068D0931 Simpex Steinmann Pin D-093 D-093 2015-09-23 B068D093121 Simpex Steinmann Pin D-093-12 D-093-12 2015-09-23 B068D09312S1 Simpex Steinmann Pin D-093-12S D-093-12S 2015-09-23 B068D093S1 Simpex Steinmann Pin D-093-S D-093-S 2015-09-23 B068D1091 Simpex Steinmann Pin D-109 D-109 2015-09-23 B068D109121 Simpex Steinmann Pin D-109-12 D-109-12 2015-09-23 B068D10912S1 Simpex Steinmann Pin D-109-12S D-109-12S 2015-09-23 B068D109S1 Simpex Steinmann Pin D-109-S D-109-S 2015-09-23 B068D1251 Simpex Steinmann Pin D-125 D-125 2015-09-23 B068D125121 Simpex Steinmann Pin D-125-12 D-125-12 2015-09-23 B068D12512S1 Simpex Steinmann Pin D-125-12S D-125-12S 2015-09-23 B068D125S1 Simpex Steinmann Pin D-125-S D-125-S 2015-09-23 B068D1401 Simpex Steinmann Pin D-140 D-140 2015-09-23 B068D140121 Simpex Steinmann Pin D-140-12 D-140-12 2015-09-23 B068D14012S1 Simpex Steinmann Pin D-140-12S D-140-12S 2015-09-23
Other Devices Sharing Product Codes# 
simpexmedical.com