FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471225985
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
R52-220
Catalog number
R52-220
Device description
BUR - SHANNON LONG HELICAL 3.0mm DIA x 20 x 70mm
Published
2026-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15051471225982PackageGS15In Commercial Distribution
05051471225985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147122598215051471225982
05051471225985050514712259855051471225985

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA 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.

Regulatory Flags#

DUNS number
458064144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051471222984De Soutter Medical21750217502026-10-01
05051471226005De Soutter Medical21670216702026-10-01
05051471226012De Soutter Medical21680216802026-10-01
05051471226029De Soutter Medical21690216902026-10-01
05051471226036De Soutter Medical21700217002026-10-01
05051471186002De Soutter Medical20250202502022-11-28
05051471186019De Soutter Medical20270202702022-11-28
05051471006942De Soutter Medical701070102022-11-28
05051471022232De Soutter Medical89522895222022-11-28
05051471040922De Soutter Medical865086502022-11-28
05051471044852De Soutter Medical882088202022-11-28
05051471005020De Soutter Medical617061702022-11-25
05051471006867De Soutter Medical75942759422022-11-25
05051471022386De Soutter Medical89932899322022-11-25
05051471027152De Soutter Medical755075502022-11-25
05051471121270De Soutter MedicalS56-703S56-7032023-06-16
05051471128217De Soutter MedicalS56-705S56-7052023-06-16
05051471118416De Soutter MedicalS56-702S56-7022023-06-16
05051471142084De Soutter Medical17670176702022-11-28
05051471225565De Soutter Medical21810218102026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
10080196377299MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10080196385577MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10884389198537MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10653160274797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160276982CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160281672CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160282402CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160290797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160321668CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10845854018125STERLINGConmed CorporationGFF2021-10-15
10845854017210STERLINGConmed CorporationGFF2021-10-14
10845854029596CONMEDConmed CorporationGFF2021-10-14
10845854029602CONMEDConmed CorporationGFF2021-10-14
10845854029619STERLING SOUTHPAWConmed CorporationGFF2021-10-14
10845854017432STERLINGConmed CorporationGFF2021-10-13
10845854017593STERLINGConmed CorporationGFF2021-10-13