Home GUDID 00817438024191 N/A
Primary DI 00817438024191
Brand N/A
Company Omega Surgical Instruments Inc
Model OZD-621
Device description 1.6 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 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 00817438024191 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 00817438024191 00817438024191 817438024191 0817438024191
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 07630008439866 APTUS Medartis AG HTW 2026-07-16 07630037811374 APTUS Medartis AG HTW 2026-07-16 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
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