FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471023727
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
S32-125
Catalog number
S32-125
Device description
SAGITTAL BLADE
Published
2022-11-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15051471023724PackageGS15Not in Commercial Distribution
05051471023727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147102372415051471023724
05051471023727050514710237275051471023727

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, single-useA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.

Regulatory Flags#

DUNS number
458064144
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
05051471023895De Soutter MedicalS33-133S33-1332022-11-22

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