FDA.reportPublic FDA data

De Soutter Medical

Primary DI
15051471152547
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
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
GEYMotor, Surgical Instrument, Ac-Powered
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1
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.

Sterilization Methods#

Method table
Method

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
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
05051471222984De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226005De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226012De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226029De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
05051471226036De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-10-01
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
05430003362112WAW SLIM HANDPIECEDevroye Instruments BelgiumGEY2026-09-21
05430003362242WAW CHARGING STATIONDevroye Instruments BelgiumGEY2026-09-21
05430003362259WAW Duo FUE SystemDevroye Instruments BelgiumGEY2026-09-21
05430003362280WAW SOFTWAREDevroye Instruments BelgiumGEY2026-09-21
00889024712300Z1 POSTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
05051471225565De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-03
05051471225541De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-01
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
05051471223844De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223851De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223868De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471219519De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-24
05051471223875De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-03
05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221703De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471028500De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2023-06-16