Home GUDID 00810168190457 NA
Primary DI 00810168190457
Brand NA
Company PACIFIC INSTRUMENTS, INC.
Model PI-3415
Device description Ø3.5mm Drill Bit, AO QC
Published 2026-05-26
Public version status New
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 00810168190457 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810168190457 00810168190457 810168190457 0810168190457
GMDN Terms# Term, Definition table Term Definition Orthopaedic bur, reusable A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 621872006 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 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 00196449017577 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04