FDA.reportPublic FDA data

Metal/carbide ENT bur, single-use

Definition
A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.
GUDID devices
817
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00199150064069ApexCutMEDTRONIC XOMED, INC.187BL40002026-04-25
00199150064076ApexCutMEDTRONIC XOMED, INC.187BL4000L2026-04-25
00199150064083ApexCutMEDTRONIC XOMED, INC.187BL40122026-04-25
00199150064090ApexCutMEDTRONIC XOMED, INC.187BL40402026-04-25
00199150064106ApexCutMEDTRONIC XOMED, INC.187BL40602026-04-25
00763000945640ApexCutMEDTRONIC XOMED, INC.187BL29002026-04-25
00763000945657ApexCutMEDTRONIC XOMED, INC.187BL35002026-04-25
00763000945695ApexCutMEDTRONIC XOMED, INC.187BL4000L2025-10-06
00763000945718ApexCutMEDTRONIC XOMED, INC.187BL35122026-04-25
00763000945732ApexCutMEDTRONIC XOMED, INC.187BL35402026-04-25
00763000945756ApexCutMEDTRONIC XOMED, INC.187BL29602026-04-24
00763000945763ApexCutMEDTRONIC XOMED, INC.187BL35602026-04-25
00763000945770ApexCutMEDTRONIC XOMED, INC.187BL40602025-10-06
00763000945787ApexCutMEDTRONIC XOMED, INC.187BL29752026-04-25
00763000945794ApexCutMEDTRONIC XOMED, INC.187BL35902026-04-25
00763000945800ApexCutMEDTRONIC XOMED, INC.187BL351202026-04-25
00821925033757DIEGOGyrus ACMI, LLC701380002018-09-12
00821925033764DiegoGyrus ACMI, LLC701380042018-09-12
00821925033771DIEGOGyrus ACMI, LLC701380052018-09-12
00821925033788DiegoGyrus ACMI, LLC701380072018-09-12
00821925033795DIEGOGyrus ACMI, LLC701380092018-09-12
00821925033801DIEGOGyrus ACMI, LLC701380132024-07-11
00821925033825DIEGOGyrus ACMI, LLC701380172018-09-12
00821925033832DIEGOGyrus ACMI, LLC701380182018-09-12
00821925033849DIEGO Gyrus ACMI, LLC701380272018-09-12
00821925033856DiegoGyrus ACMI, LLC701380332018-09-12
00821925033863DiegoGyrus ACMI, LLC701380352018-09-12
00821925033887DiegoGyrus ACMI, LLC701381002018-09-12
00821925033894DIEGOGyrus ACMI, LLC701390002024-07-25
00821925034181DIEGO Gyrus ACMI, LLC701380032018-09-12
00821925034198DIEGOGyrus ACMI, LLC701380022018-09-12
00821925034211DIEGOGyrus ACMI, LLC701380212018-09-12
00821925034228DiegoGyrus ACMI, LLC701380062018-09-12
00821925034259DIEGOGyrus ACMI, LLC701390102024-07-25
00821925034273DIEGOGyrus ACMI, LLC701380162018-09-12
00821925034280DIEGOGyrus ACMI, LLC701380122018-09-12
00821925034297DIEGOGyrus ACMI, LLC701380112018-09-12
00821925034310DIEGOGyrus ACMI, LLC701380102018-09-12
00821925034327DIEGO Gyrus ACMI, LLC701380312018-09-12
00821925034334DIEGO Gyrus ACMI, LLC701380342018-09-12
00821925034341DiegoGyrus ACMI, LLC701380252018-09-12
00821925034358DiegoGyrus ACMI, LLC701380232018-09-12
00821925034365DiegoGyrus ACMI, LLC701380242018-09-12
00821925034372DIEGO Gyrus ACMI, LLC701380282018-09-12
00821925034389DiegoGyrus ACMI, LLC701380222018-09-12
00821925034396DIEGO Gyrus ACMI, LLC701380262018-09-12
00821925034402DiegoGyrus ACMI, LLC701380302018-09-12
00821925034426DIEGOGyrus ACMI, LLC701380012018-09-12
00821925034570DiegoGyrus ACMI, LLC702361012018-09-12
00821925034600DiegoGyrus ACMI, LLC701380322018-09-12
00821925034624DIEGO Gyrus ACMI, LLC701380462018-09-12
00821925034631DIEGO Gyrus ACMI, LLC701380472018-09-12
00821925034693DiegoGyrus ACMI, LLC701380292018-09-12
00821925034983DIEGOGyrus ACMI, LLC701382002018-09-12
00821925035140DIEGO ELITEGyrus ACMI, LLCSB4800SA2018-09-14
00821925037779DIEGOGyrus ACMI, LLC701380082018-09-12
00821925037786DiegoGyrus ACMI, LLC701382082018-09-12
00821925037823DiegoGyrus ACMI, LLC702361062018-09-12
00821925037830DiegoGyrus ACMI, LLC702361072018-09-12
00821925038677DIEGO ELITEGyrus ACMI, LLCSB2940SS2018-09-14
00821925038684DIEGO ELITEGyrus ACMI, LLCSB2975SC2018-09-14
00821925038691DIEGO ELITEGyrus ACMI, LLCSB2975SS2018-09-14
00821925038707DIEGO ELITEGyrus ACMI, LLCSB4000SA2018-09-14
00821925038714DIEGO ELITEGyrus ACMI, LLCSB4000SS2018-09-14
00821925038721DIEGO ELITEGyrus ACMI, LLCSB4015SS2018-09-14
00821925038738DIEGO ELITEGyrus ACMI, LLCSB4040RS2018-09-14
00821925038745DIEGO ELITEGyrus ACMI, LLCSB4040SS2018-09-14
00821925038752DIEGO ELITEGyrus ACMI, LLCSB4060RS2018-09-14
00821925038769DIEGO ELITEGyrus ACMI, LLCSB4060SC2018-09-14
00821925038776DIEGO ELITEGyrus ACMI, LLCSB4060SS2018-09-14
00821925038783DIEGO ELITEGyrus ACMI, LLCSB4090RS2018-09-14
00821925040403DIEGOGyrus ACMI, LLC701380152018-09-12
00821925040410DiegoGyrus ACMI, LLC701380432018-09-12
00821925040427DiegoGyrus ACMI, LLC701380502018-09-12
00821925040434DiegoGyrus ACMI, LLC701380512018-09-12
00821925040441DiegoGyrus ACMI, LLC701380522018-09-12
00821925040458DiegoGyrus ACMI, LLC701381062018-09-12
00821925040465DIEGOGyrus ACMI, LLC701382092018-09-12
00821925040472Gyrus ACMIGyrus ACMI, LLC701384002017-05-10
00821925040601DIEGO ELITEGyrus ACMI, LLCBUR4215FB2018-09-13