FDA.reportPublic FDA data

Orthopaedic bur, single-use

Definition
A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/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/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.
GUDID devices
19,476
Last updated
2026-10-29 05:55:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05051471027725De Soutter MedicalDE SOUTTER MEDICAL LIMITEDR25-2092022-11-29
05051471030152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDR25-3082022-11-29
05051471089792De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-05502022-11-29
05051471089808De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-05602022-11-29
05051471089815De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-05702022-11-29
05051471089839De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-05102022-11-29
05051471089853De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-05302022-11-29
05051471089877De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-05502022-11-29
05051471089907De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH53-05502022-11-29
05051471089938De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-07202022-11-29
05051471089976De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-07602022-11-29
05051471089983De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-07702022-11-29
05051471090019De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-07202022-11-29
05051471090033De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-07402022-11-29
05051471090057De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-07602022-11-29
05051471090064De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-07702022-11-29
05051471090071De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH53-07502022-11-29
05051471090095De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH54-07302022-11-29
05051471090118De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-09302022-11-29
05051471090132De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-09502022-11-29
05051471090187De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-11302022-11-29
05051471090200De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-11502022-11-29
05051471090217De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH50-11602022-11-29
05051471090231De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-11202022-11-29
05051471090248De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH51-11302022-11-29
05051471090255De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH54-11302022-11-29
05051471090262De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH57-12182022-11-29
05051471090279De Soutter MedicalDE SOUTTER MEDICAL LIMITEDH57-16182022-11-29
08053782784752BURRSBRM EXTREMITIES SRLCR 2020 60 S2026-10-19
00817438028762N/AOmega Surgical Instruments IncS702L-60-01NS2026-10-05
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDR52-2202026-08-01
00817438028724N/AOmega Surgical Instruments IncMR15BA502026-07-24
00817438028755N/AOmega Surgical Instruments IncES-071-0582026-07-21
07630037811374APTUSMedartis AGA-3837S2026-07-16
07899258638867Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Shannon Short2024-01-11
07899258638874Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Shannon Straight2024-01-11
07899258638881Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Wedge2024-01-11
07899258638898Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Extra Wedge2024-01-11
07899258638911Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Conical2024-01-11
07899258638928Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Shannon Long2024-01-11
07899258658230Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Shannon Straight Long2024-01-15
07899258658247Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Cylindrical2024-01-15
07899258658254Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Cylindrical2024-01-15
07899258658261Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Cylindrical2024-01-15
07899258658278Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Flame2024-01-15
07899258658285Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDABurrs Spheric2024-01-15
00763000003982Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSMR8-14RT642020-11-14
00763000357108ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B60SCF2020-10-05
00763000357115ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B50SCF2020-10-05
00763000357122ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B40SCF2020-10-05
00763000357139ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B30SCF2020-10-05
00763000357146ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B25SCF2020-10-05
00763000357153ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B20SCF2020-10-05
00763000357160ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B15SCF2020-10-05
00763000357177ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10SCF2020-10-05
00763000357184ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B35LCF2020-10-05
00763000357191ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B30LCF2020-10-05
00763000357207ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B25LCF2020-10-05
00763000357214ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B20LCF2020-10-05
00763000357221ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B15LCF2020-10-05
00763000357238ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10LCF2020-10-05
00763000357245ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B80SCT2020-10-05
00763000357252ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B70SCT2020-10-05
00763000357269ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B60SCT2020-10-05
00763000357276ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B50SCT2020-10-05
00763000514020MIDAS REX CURVED BURMEDTRONIC POWERED SURGICAL SOLUTIONSMR8-SP14MH30T2022-04-22
00763000714499MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSMR8-14BA30SH2025-01-16
00763000714505MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSMR8-14BA20SH2025-01-16
00763000714604MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSMR8-10BA50SH2025-01-16
00763000753061ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B05LCT2022-12-26
00763000753078ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B06LDM2022-12-26
00763000753085ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B08LDM2022-12-26
00763000753092ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10LCF2022-12-26
00763000753108ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10LCT2022-12-26
00763000753115ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10LDC2022-12-26
00763000753122ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10LDF2022-12-26
00763000753139ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10LDM2022-12-26
00763000753146ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10SCC2022-12-26
00763000753153ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10SCF2022-12-26
00763000753160ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONS1847B10SCT2022-12-26