Home GUDID 00817438026027 N/A
Primary DI 00817438026027
Brand N/A
Company Omega Surgical Instruments Inc
Model X-21568
Device description 4.0 MM X 2.35 MM X 64.0 MM ROUND DIAMOND BUR
Published 2022-06-03
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 GFF Bur, Surgical, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817438026027 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 00817438026027 00817438026027 817438026027 0817438026027
GMDN Terms# Term, Definition table Term Definition Diamond ENT bur, single-use A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. 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 10080196377244 MEDLINE MEDLINE INDUSTRIES, INC. GFF 2025-01-29 10080196385560 MEDLINE MEDLINE INDUSTRIES, INC. GFF 2025-01-29 10845854012581 VORTEX, STERLING Conmed Corporation GFF 2023-01-19 10845854012598 VORTEX, STERLING Conmed Corporation GFF 2023-01-19 10845854017791 STERLING Conmed Corporation GFF 2023-01-19 10845854029626 STERLING Conmed Corporation GFF 2023-01-19 10845854029671 LIGHTNING, STERLING Conmed Corporation GFF 2023-01-19 10845854040621 ULTRATIGER Conmed Corporation GFF 2023-01-19 10080196377299 Medline MEDLINE INDUSTRIES, INC. GFF 2022-05-12 10080196385577 Medline MEDLINE INDUSTRIES, INC. GFF 2022-05-12 10884389198537 Medline MEDLINE INDUSTRIES, INC. GFF 2022-05-12 10653160274797 Centurion CENTURION MEDICAL PRODUCTS CORPORATION GFF 2022-01-01 10653160276982 Centurion CENTURION MEDICAL PRODUCTS CORPORATION GFF 2022-01-01 10653160281672 Centurion CENTURION MEDICAL PRODUCTS CORPORATION GFF 2022-01-01 10653160282402 Centurion CENTURION MEDICAL PRODUCTS CORPORATION GFF 2022-01-01 10653160290797 Centurion CENTURION MEDICAL PRODUCTS CORPORATION GFF 2022-01-01 10653160321668 Centurion CENTURION MEDICAL PRODUCTS CORPORATION GFF 2022-01-01 10845854018125 STERLING Conmed Corporation GFF 2021-10-15 10845854017210 STERLING Conmed Corporation GFF 2021-10-14 10845854029596 CONMED Conmed Corporation GFF 2021-10-14 10845854029602 CONMED Conmed Corporation GFF 2021-10-14 10845854029619 STERLING SOUTHPAW Conmed Corporation GFF 2021-10-14 10845854017432 STERLING Conmed Corporation GFF 2021-10-13 10845854017593 STERLING Conmed Corporation GFF 2021-10-13 10845854036563 STERLING SOUTHPAW Conmed Corporation GFF 2021-10-13 10845854000687 CONMED Conmed Corporation GFF 2020-09-24 10845854000717 CONMED Conmed Corporation GFF 2020-09-24 10845854000724 CONMED Conmed Corporation GFF 2020-09-24 10845854000755 CONMED Conmed Corporation GFF 2020-09-24 10845854000779 CONMED Conmed Corporation GFF 2020-09-24
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