FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471220836
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
S83-8169
Catalog number
S83-8169
Device description
RECIP. BLADE - DE SOUTTER RASP 2.4 x 12.5 x 6.50mm
Published
2026-03-02
Public version status
New
Distribution status
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
05051471220836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051471220836050514712208365051471220836

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, reciprocating, single-useA sterile, 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 dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.

Sterilization Methods#

Method table
Method

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
05051471186002De Soutter Medical20250202502022-11-28
05051471186019De Soutter Medical20270202702022-11-28
05051471006942De Soutter Medical701070102022-11-28
05051471022232De Soutter Medical89522895222022-11-28
05051471040922De Soutter Medical865086502022-11-28
05051471044852De Soutter Medical882088202022-11-28
05051471005020De Soutter Medical617061702022-11-25
05051471006867De Soutter Medical75942759422022-11-25
05051471022386De Soutter Medical89932899322022-11-25
05051471027152De Soutter Medical755075502022-11-25
05051471121270De Soutter MedicalS56-703S56-7032023-06-16
05051471128217De Soutter MedicalS56-705S56-7052023-06-16
05051471118416De Soutter MedicalS56-702S56-7022023-06-16
05051471142084De Soutter Medical17670176702022-11-28
05051471225565De Soutter Medical21810218102026-08-03
05051471225541De Soutter Medical21800218002026-08-01
05051471225985De Soutter MedicalR52-220R52-2202026-08-01
05051471223844De Soutter Medical21710217102026-07-21
05051471223851De Soutter Medical21720217202026-07-21
05051471223868De Soutter Medical21730217302026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430003362112WAW SLIM HANDPIECEDevroye Instruments BelgiumGEY2026-09-21
05430003362242WAW CHARGING STATIONDevroye Instruments BelgiumGEY2026-09-21
05430003362259WAW Duo FUE SystemDevroye Instruments BelgiumGEY2026-09-21
05430003362280WAW SOFTWAREDevroye Instruments BelgiumGEY2026-09-21
00889024712300Z1 POSTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
05051471225565De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-03
05051471225541De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-01
05051471223844De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223851De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223868De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471219519De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-24
05051471223875De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-03
05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221703De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
10817417021323AsepticoASEPTICO, INC.GEY2026-04-08
10817417021330AsepticoASEPTICO, INC.GEY2026-04-08
10845854013144ERGOConmed CorporationGEY2026-03-24
00193982678265VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678326VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
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00193982679163VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27