Home GUDID 00817438024139 N/A
Primary DI 00817438024139
Brand N/A
Company Omega Surgical Instruments Inc
Model OSD-835
Device description 3.5 MM X 110.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
Published 2022-05-31
Public version status New
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 00817438024139 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 00817438024139 00817438024139 817438024139 0817438024139
GMDN Terms# Term, Definition table Term Definition Fluted surgical drill bit, single-use 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 mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 808825038 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label 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 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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