FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471058989
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
11020
Catalog number
11020
Device description
HOSE ASSY - MPZ HEYER 3 METRE
Published
2022-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GETMotor, Surgical Instrument, Pneumatic Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GETMotor, Surgical Instrument, Pneumatic PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051471058989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051471058989050514710589895051471058989

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic surgical power tool hoseA single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed surgical-grade air or nitrogen (N2) gas from a gas source, usually the central medical gas supply system, to a surgical drilling system or sawing system handpiece or motor to supply it with power. The device is usually from 2 to 5 meters in length and is commonly designed according to ISO5359. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
458064144
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051471220195De Soutter Medical21630216302026-03-24
05051471011519De Soutter Medical517051702022-11-28
05051471220812De Soutter MedicalS83-8069S83-80692026-03-02
05051471220836De Soutter MedicalS83-8169S83-81692026-03-02
05051471220263De Soutter MedicalS89-1482S89-14822026-01-29
05051471219625De Soutter MedicalS83-9499S83-94992026-01-05
05051471198777De Soutter MedicalT20-101T20-1012023-06-16
05051471197220De Soutter Medical20460204602023-06-16
05051471215283De Soutter Medical21530215302025-12-04
05051471219038De Soutter MedicalS83-9399S83-93992025-12-04
05051471219175De Soutter MedicalS56-9655S56-96552025-12-04
05051471219199De Soutter MedicalS89-9655S89-96552025-12-04
05051471044845De Soutter Medical881088102022-11-28
05051471078581De Soutter Medical128277412827742022-11-25
05051471023321De Soutter MedicalS12-272S12-2722022-11-22
05051471023727De Soutter MedicalS32-125S32-1252022-11-22
05051471023765De Soutter MedicalS32-129S32-1292022-11-22
05051471023802De Soutter MedicalS32-135S32-1352022-11-22
05051471023840De Soutter MedicalS33-123S33-1232022-11-22
05051471023864De Soutter MedicalS33-125S33-1252022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809317170671LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170701LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170817LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317171012LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170657LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170664LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170695LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170824LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08800038048270LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048287LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048294LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048300LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038053151LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038055421LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055438LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055445LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055469LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08809317170800LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048645LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038048652LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038055452LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
06946998817265BojinShanghai Bojin Electric Instrument & Device Co., Ltd.GET2022-12-29
05051471038820De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471047631De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471085596De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471098152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471105577De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471107397De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471107410De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471109773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28