FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05060528013208
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
15250
Catalog number
15250
Device description
BP-201 BATTERY PACK - PRO
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
05060528013208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060528013208050605280132085060528013208

GMDN Terms#

Term, Definition table
TermDefinition
Portable/mobile rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

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
05060528013192De 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