FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471089839
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
H51-0510
Catalog number
H51-0510
Device description
HST BUR - ROUND DIAMOND FINE 1.0mm DIA x 91mm
Published
2022-11-29
Public version status
Update
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
15051471089836PackageGS15In Commercial Distribution
05051471089839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147108983615051471089836
05051471089839050514710898395051471089839

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
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
05051471089853De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089877De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089907De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29