Home GUDID 00613994453099 N/A
Primary DI 00613994453099
Brand N/A
Company MEDTRONIC SOFAMOR DANEK, INC.
Model X0308004
Device description DRILL BIT X0308004 ADJUSTABLE
Published 2017-12-17
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 00613994453099 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 00613994453099 00613994453099 613994453099 0613994453099
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 830350380 Device count 1 Premarket exempt true 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 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 00196449017584 A.L.P.S. mvX™ Tyber Medical, LLC HTW 2026-06-04 00810030811657 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTW 2026-06-01 00810030811671 InSitu Hip System NEXTSTEP ARTHROPEDIX, LLC HTW 2026-06-01 04052536161836 neon3 Ulrich GmbH & Co. KG HTW 2026-05-28 04052536161867 neon3 Ulrich GmbH & Co. KG HTW 2026-05-28 09120125220273 Shark Screw® drill surgebright GmbH HTW 2026-04-30 08053782783724 BRM TOOL VIP SCREWS INSTRUMENT BRM EXTREMITIES SRL HTW 2026-04-29 08059386744260 Orthopaedic Surgical Instruments CITIEFFE SRL HTW 2025-11-06 08059386744277 Orthopaedic Surgical Instruments CITIEFFE SRL HTW 2025-11-06 08059386742327 Orthopaedic Surgical Instruments CITIEFFE SRL HTW 2025-11-05
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