FDA.report

De Soutter Medical

Primary DI
15051471081069
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
S87-256
Catalog number
S87-256
Device description
SAGITTAL BLADE - DE SOUTTER OPPOSED 33 x 65 x 0.95mm
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15051471081069PackageGS15In Commercial Distribution
05051471081062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1505147108106915051471081069
05051471081062050514710810625051471081062

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
458064144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05051471220195De Soutter Medical21630216302026-03-24
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
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
05051471214453De Soutter Medical21440214402025-09-17
05051471214460De Soutter Medical21450214502025-09-17
05051471214477De Soutter Medical21460214602025-09-17
05051471214484De Soutter Medical21470214702025-09-17
05051471214491De Soutter Medical21480214802025-09-17
05051471214507De Soutter Medical21490214902025-09-17
15051471214788De Soutter MedicalT20-110T20-1102025-09-12
15051471214795De Soutter MedicalT20-173T20-1732025-09-12
15051471217123De Soutter MedicalT20-171T20-1712025-09-12
15051471217130De Soutter MedicalT20-172T20-1722025-09-12
05051471217140De Soutter Medical21520215202025-09-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05051471220195De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-24
00889024706538REDUCED ZIMMER ANT ADAPTERZimmer, Inc.GEY2026-03-19
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07613327656770BPXSTRYKER CORPORATIONGEY2026-03-04
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07613327657777BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657784BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657791BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657814BPXSTRYKER CORPORATIONGEY2026-03-04
07613327659429BPXSTRYKER CORPORATIONGEY2026-03-04
05051471220812De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220836De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220263De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-29
00193982678906VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678913VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678920VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678982VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679002VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679286VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
05051471219625De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-05
04055207036693POWER STICK M5/0Richard Wolf GmbHGEY2025-12-18
05051471215283De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219038De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219175De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219199De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471214453De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214460De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214477De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214484De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214491De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17