FDA.report

De Soutter Medical

Primary DI
05051471154773
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
18260
Catalog number
18260
Device description
SU-472 SAGITTAL SAW HEAD - ROTATING (S86)
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
05051471154773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051471154773050514711547735051471154773

GMDN Terms

TermDefinition
Sawing power tool attachment, sagittalA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a sagittal sawing function when a sagittal saw blade is inserted. This attachment is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward and cuts when the blade is powered in a rapid oscillating (side to side) movement. It is typically made of high-grade stainless steel and synthetic materials and is typically of the macro design. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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05051471220195De Soutter Medical21630216302026-03-24
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05051471214460De Soutter Medical21450214502025-09-17
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05051471214484De Soutter Medical21470214702025-09-17
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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

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05051471219625De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-05
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05051471215283De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
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05051471214477De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
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05051471214491De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17