FDA.reportPublic FDA data

Cranial bur, single-use

Definition
A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.
GUDID devices
2,187
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841019107690KirwanKIRWAN SURGICAL PRODUCTS LLC40-10002016-05-08
00841019107706KirwanKIRWAN SURGICAL PRODUCTS LLC40-10012016-05-08
00841019107713KirwanKIRWAN SURGICAL PRODUCTS LLC40-10032016-05-08
04251388960080HiCUT Bursadeor Medical AG2.2 mm neuro Matchstick, MR conditional2026-03-30
04251388960097HiCUT Bursadeor Medical AG4.8 mm balltip, MR conditional2026-03-30
04251388960103HiCUT Bursadeor Medical AG3.4 mm drill, MR conditional2026-03-30
04251388960110HiCUT Bursadeor Medical AG4.5 mm drill, MR conditional2026-03-30
04251388961278PMT Drill Cutter adeor Medical AG2.2 x 20 mm2026-04-02
17630055503074Bur PM2-95 80K Mstick Ø1.8 StBien-Air Surgery SA11003362023-02-08
17630055503081Bur PM2-95 80K Mstick Ø3.0 StBien-Air Surgery SA11003372023-02-08
17630055503104Bur PM2-95 80K Drum Ø5.0x10 StBien-Air Surgery SA11003392023-02-08
17630055503111Bur PM2-125 80K Mstick Ø1.8 StBien-Air Surgery SA11003402023-02-08
17630055503128Bur PM2-125 80K Mstick Ø3.0 StBien-Air Surgery SA11003412023-02-08
17630055503135Bur PM2-125 80K DrumC Ø4x8 StBien-Air Surgery SA11003422023-02-08
17630055503142Bur PM2-125 80K Drum Ø5x10 StBien-Air Surgery SA11003432023-02-08
17630055503494Bur Cranial Straight 10mm StBien-Air Surgery SA11003832023-02-09
17630055503517Bur Cranial Spiral 10mm StBien-Air Surgery SA11003862023-02-09
17630055503524Bur Cranial Straight 15mm StBien-Air Surgery SA11003872023-02-09
17630055503715Bur Cranial Straight 25 mm StBien-Air Surgery SA11004142023-02-09
17630055504149Bur PM2 80K Steel TD Ø1.5x12 StBien-Air Surgery SA11004592023-02-09
17630055504156Bur PM2-70 80K Mstick Ø1.8 StBien-Air Surgery SA11004602023-02-09
17630055504163Bur PM2-70 80K Mstick Ø3.0 StBien-Air Surgery SA11004612023-02-09
17630055504279Bur PM2 80K Steel TD Ø1.1x4 StBien-Air Surgery SA11004722023-02-09
17630055506990HS Diam. Burr, Ø1.0x70, 80kBien-Air Surgery SA360210 ES2023-02-22
17630055507041HS Diam. Burr, Ø5.0x70, 80kBien-Air Surgery SA360250 ES2023-02-22
17630055507096HS Stand. Burr, Ø3.1x70, 80kBien-Air Surgery SA360131 ES2023-02-22
17630055507461HS Craniotome Burr, short, 80kBien-Air Surgery SA362640 S2023-02-22
17630055507478HS Craniotome Burr,medium,80kBien-Air Surgery SA362640 M2023-02-22
17630055507485HS Craniotome Burr, long 80kBien-Air Surgery SA362640 L2023-02-22
17630055507492HS Matchstick Burr,Ø1.8x95,80KBien-Air Surgery SA361118 S2023-02-22
17630055507508HS Matchstick Burr,Ø3.0x95,80KBien-Air Surgery SA361130 S2023-02-22
17630055507515HS Barr.Burr,Ø4.0x8.0x95,80kBien-Air Surgery SA360940 S2023-02-22
17630055507522HS Barr.Burr,Ø5.0x10.0x95,80kBien-Air Surgery SA360950 S2023-02-22
17630055507539HS Matchstick Bur,Ø1.8x125,80KBien-Air Surgery SA361118 M2023-02-22
17630055507546HS Matchstick Bur,Ø3.0x125,80KBien-Air Surgery SA361130 M2023-02-22
17630055507553HS Barr.Burr,Ø4.0x8.0x125,80kBien-Air Surgery SA360940 M2023-02-22
17630055507560HS Barr.Burr,Ø5.0x10.0x125,80kBien-Air Surgery SA360950 M2023-02-22
17630055507577HS Twist Burr, Ø1.5x12, 80kBien-Air Surgery SA361115 ES2023-02-22
17630055507584HS Matchstick Burr,Ø1.8x70,80KBien-Air Surgery SA361118 ES2023-02-22
17630055507591HS Matchstick Burr,Ø3.0x70,80KBien-Air Surgery SA361130 ES2023-02-22
17630055507607HS Matchstick Bur,Ø1.8x150,80KBien-Air Surgery SA361118 L2023-02-22
17630055507614HS Matchstick Bur,Ø3.0x150,80KBien-Air Surgery SA361130 L2023-02-22
J00711003830011Bur PM2-70 cranial straight 10mm sterileBien-Air Surgery SA11003832019-01-08
J00711003840011Bur PM2-70 cranial straight 15mm sterileBien-Air Surgery SA11003842019-01-08
J00711003860011Bur PM2-70 cranial spiral 10mm sterileBien-Air Surgery SA11003862019-01-08
J00711003870011Bur PM2-70 cranial spiral 15mm sterileBien-Air Surgery SA11003872019-01-08
J00711004130011Bur PM2-70 cranial spiral 25mm sterileBien-Air Surgery SA11004132019-01-08
J00711004140011Bur PM2-70 cranial straight 25mm sterileBien-Air Surgery SA11004142019-01-08
J00711004810011Bur PM2-150 80K Matchstick Ø1.8mm sterileBien-Air Surgery SA11004812019-01-07
04251388960387HiCUT Bursadeor Medical AG7.5 mm balltip2025-04-30
04251388958315HiCUT Bursadeor Medical AG4.0 mm balltip, smooth cut2025-04-29
04251388959855HiCUT Bursadeor Medical AG8.0 mm diamond ball standard2025-04-29
04251388959985HiCUT Bursadeor Medical AG3.2 mm balltip, smooth cut2025-04-29
04251388959992HiCUT Bursadeor Medical AG5.0 mm balltip, smooth cut2025-04-29
04251388960004HiCUT Bursadeor Medical AG6.0 mm balltip, smooth cut2025-04-29
04251388941102PMT Drill Cutteradeor Medical AG2.1mmx254mm(10in.)2025-04-25
04251388941119PMT Drill Cutteradeor Medical AG2.4mmX254mm(10in.)2025-04-25
04251388958339PMT Drill Cutteradeor Medical AG2.2mmX254mm(10in.)2025-04-25
04251388961025PMT Drill Cutteradeor Medical AG3.2mmX254mm(10in.)2025-04-25
10705034646091VELYSMedos International Sàrl4516110572025-03-28
10705034646107VELYSMedos International Sàrl4516110582025-03-28
17630055513790Bur PM2 80K Steel TD Ø1.1x4 StBien-Air Surgery SA11012472024-12-04
17630055513813Bur Cranial Straight 25 mm StBien-Air Surgery SA11012402024-12-04
17630055513820Bur Cranial Spiral 25mm StBien-Air Surgery SA11012392024-12-04
17630055513837Bur Cranial Spiral 10mm StBien-Air Surgery SA11012352024-12-04
17630055513844Bur Cranial Straight 10mm StBien-Air Surgery SA11012342024-12-04
17630055513851Bur PM2-150 80K Mstick Ø3.0 StBien-Air Surgery SA11012512024-12-04
17630055513868Bur PM2-150 80K Mstick Ø1.8 StBien-Air Surgery SA11012502024-12-04
J00711004820011Bur PM2-150 80K Matchstick Ø3.0mm sterileBien-Air Surgery SA11004822019-01-07
04589551363063NSK Sterile Burs/DrillsNAKANISHI INC.PDS-WSP-M2023-09-18
04589551363070NSK Sterile Burs/DrillsNAKANISHI INC.PDS-WSP-L2023-09-18
27630055506997HS Diam. Burr, Ø1.0x70, 80kBien-Air Surgery SA360210 ES2023-02-22
27630055507048HS Diam. Burr, Ø5.0x70, 80kBien-Air Surgery SA360250 ES2023-02-22
27630055507093HS Stand. Burr, Ø3.1x70, 80kBien-Air Surgery SA360131 ES2023-02-22
27630055507468HS Craniotome Burr, short, 80kBien-Air Surgery SA362640 S2023-02-22
27630055507475HS Craniotome Burr,medium,80kBien-Air Surgery SA362640 M2023-02-22
27630055507482HS Craniotome Burr, long 80kBien-Air Surgery SA362640 L2023-02-22
27630055507499HS Matchstick Burr,Ø1.8x95,80KBien-Air Surgery SA361118 S2023-02-22
27630055507505HS Matchstick Burr,Ø3.0x95,80KBien-Air Surgery SA361130 S2023-02-22
27630055507512HS Barr.Burr,Ø4.0x8.0x95,80kBien-Air Surgery SA360940 S2023-02-22