Home GUDID 00850003396279 N/A
Primary DI 00850003396279
Brand N/A
Company Artelon
Model 61015
Catalog number 61015
Device description Cannulated Drill Bit
Published 2023-05-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile 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 00850003396279 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 00850003396279 00850003396279 850003396279 0850003396279
GMDN Terms# Term, Definition table Term Definition Cannulated surgical drill bit, single-use A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 4.5 Millimeter
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 066284070 Device count 1 Premarket exempt true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 08059386742341 Orthopaedic Surgical Instruments CITIEFFE SRL HTW 2025-11-05 08059386742358 Orthopaedic Surgical Instruments CITIEFFE SRL HTW 2025-11-05
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