FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471152540
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
R60-201
Catalog number
R60-201
Device description
BUR - DISC CUTTER DIAMOND 25.4mm DIA x 62mm
Published
2022-11-24
Public version status
Update
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
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
15051471152547PackageGS15In Commercial Distribution
05051471152540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147115254715051471152547
05051471152540050514711525405051471152540

GMDN Terms#

Term, Definition table
TermDefinition
Metal-cutting burA rotary cutting device consisting of a shaft and a cutting working end made of hard materials (e.g., high-grade steel, carbide, diamond) which is designed to fit into an appropriate powered handpiece that provides the rotation, and is intended for cutting hard metal, typically a device/implant during orthopaedic surgery. This is a single-use device.

Regulatory Flags#

DUNS number
458064144
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051471221512De Soutter MedicalT20-122T20-1222026-05-27
05051471221697De Soutter Medical21640216402026-05-27
05051471221703De Soutter Medical21650216502026-05-27
05051471221710De Soutter Medical21660216602026-05-27
05051471220195De Soutter Medical21630216302026-03-24
05051471011519De Soutter Medical517051702022-11-28
05051471220812De Soutter MedicalS83-8069S83-80692026-03-02
05051471220836De Soutter MedicalS83-8169S83-81692026-03-02
05051471220263De Soutter MedicalS89-1482S89-14822026-01-29
05051471219625De Soutter MedicalS83-9499S83-94992026-01-05
05051471198777De Soutter MedicalT20-101T20-1012023-06-16
05051471197220De Soutter Medical20460204602023-06-16
05051471215283De Soutter Medical21530215302025-12-04
05051471219038De Soutter MedicalS83-9399S83-93992025-12-04
05051471219175De Soutter MedicalS56-9655S56-96552025-12-04
05051471219199De Soutter MedicalS89-9655S89-96552025-12-04
05051471044845De Soutter Medical881088102022-11-28
05051471078581De Soutter Medical128277412827742022-11-25
05051471023321De Soutter MedicalS12-272S12-2722022-11-22
05051471023727De Soutter MedicalS32-125S32-1252022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
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
10845854036563STERLING SOUTHPAWConmed CorporationGFF2021-10-13
10845854000687CONMEDConmed CorporationGFF2020-09-24
10845854000717CONMEDConmed CorporationGFF2020-09-24
10845854000724CONMEDConmed CorporationGFF2020-09-24
10845854000755CONMEDConmed CorporationGFF2020-09-24
10845854000779CONMEDConmed CorporationGFF2020-09-24