FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05060528013192
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
1286994
Catalog number
1286994
Device description
CSP-201 QUIETCAST PAEDIATRIC SAW
Published
2025-05-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LGHInstrument, Cast Removal, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGHInstrument, Cast Removal, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060528013192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060528013192050605280131925060528013192

GMDN Terms#

Term, Definition table
TermDefinition
Cast cutter, electrically-poweredA hand-held, electrically-powered device designed for cutting the plaster or synthetic material used to form casts typically during the removal process. The proximal end is usually cylindrical, forming the handle of the device, whilst the distal end terminates in a rounded, half moon-like, or circular blade capable of cutting the material used to form casts. The cutting capability of the blade is provided by an electric motor in the handle which vibrates or rotates the blade. Cutting is effected by vibration or rotation rather than sawing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458064144
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051471001169De Soutter Medical124012402022-11-28
05051471002623De Soutter Medical161016102022-11-28
05051471009585De Soutter Medical30062300622022-11-28
05051471010697De Soutter Medical390039002022-11-28
05051471011441De Soutter Medical511051102022-11-28
05051471011519De Soutter Medical517051702022-11-28
05051471022348De Soutter Medical89852898522022-11-28
05051471036239De Soutter Medical793079302022-11-28
05051471037281De Soutter Medical812081202022-11-28
05051471040649De Soutter Medical794079402022-11-28
05051471041578De Soutter Medical878087802022-11-28
05051471045057De Soutter Medical795079502022-11-28
05051471061545De Soutter Medical6229336229332022-11-28
05051471112711De Soutter Medical15090150902022-11-28
05051471120976De Soutter Medical6503036503032022-11-28
05051471015432De Soutter Medical6027636027632022-11-25
05051471112308De Soutter Medical15030150302022-11-25
05051471176980De Soutter Medical6701136701132022-11-25
05051471176997De Soutter Medical6701236701232022-11-25
05051471222984De Soutter Medical21750217502026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471208803De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-06-17
05060528013208De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013215De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013222De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
04042809703535Delta-Cast SereneBSN MEDICAL, INC.LGH2025-03-07
04042809721966Delta-Cast SereneBSN MEDICAL, INC.LGH2025-03-07
05051471208773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471208780De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471208797De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471000513De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471000766De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471000773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471001398De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471001824De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471005198De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471005204De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006355De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006362De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006379De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006386De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006409De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006959De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471009646De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471011458De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471011465De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471012332De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471015364De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471015432De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471016163De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471018693De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25