Home GUDID H980035014160 NA
Primary DI H980035014160
Brand NA
Company SYNTHES (U.S.A.) LP
Model 03.501.416
Catalog number 03501416
Device description 1.5MM DRILL BIT HEX COUPLING WITH 16MM STOP/82MM
Published 2018-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 10887587011127 Primary GS1 0 H980035014160 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10887587011127 10887587011127
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 832637081 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00190776395438 Millennium Avalign Technologies, Inc. HTW 2026-07-13 00190446932406 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 00190446948216 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 00190446948483 Arsenal Foot Trilliant Surgical, LLC HTW 2026-06-25 09353903030218 Griplasty System FIELD ORTHOPAEDICS PTY LTD HTW 2026-06-24 00889795154507 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154514 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154521 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 00889795154606 Spider Monkey Bone Transport System Paragon 28, Inc. HTW 2026-06-10 08800089483433 Drill bit Jeil Medical Corporation HTW 2026-06-10 08800089483457 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTW 2026-06-10 04052536176700 neon3 Ulrich GmbH & Co. KG HTW 2026-06-08 04052536176717 neon3 Ulrich GmbH & Co. KG HTW 2026-06-08 00196449017355 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017362 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017409 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017416 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017423 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017430 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017447 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017461 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017478 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017485 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017492 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017508 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017515 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017522 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017539 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017546 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00196449017560 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04
xx.xx