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
05051471023413De Soutter MedicalS17-036S17-0362022-11-22
05051471023758De Soutter MedicalS32-128S32-1282022-11-22
05051471023888De Soutter MedicalS33-132S33-1322022-11-22
05051471027725De Soutter MedicalR25-209R25-2092022-11-29
05051471028074De Soutter MedicalS92-120S92-1202022-11-22
05051471028098De Soutter MedicalS92-121S92-1212022-11-22
05051471028111De Soutter MedicalS92-122S92-1222022-11-22
05051471028135De Soutter MedicalS92-123S92-1232022-11-22
05051471028159De Soutter MedicalS92-124S92-1242022-11-22
05051471028173De Soutter MedicalS92-125S92-1252022-11-22
05051471028197De Soutter MedicalS92-126S92-1262022-11-22
05051471028258De Soutter MedicalS92-133S92-1332022-11-22
05051471028272De Soutter MedicalS92-220S92-2202022-11-18
05051471028296De Soutter MedicalS92-221S92-2212022-11-18
05051471028319De Soutter MedicalS92-224S92-2242022-11-23
05051471028333De Soutter MedicalS92-226S92-2262022-11-23
05051471028371De Soutter MedicalS92-234S92-2342022-11-23
05051471028395De Soutter MedicalS92-236S92-2362022-11-23
05051471028418De Soutter MedicalS92-263S92-2632022-11-23
05051471028432De Soutter MedicalS92-140S92-1402022-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
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
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
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
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000108G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000109G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000106AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-27
E226000104AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
E226000104G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
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
05051471027725De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471030152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089792De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089808De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089815De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089839De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089853De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089877De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29