FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471153684
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
18230
Catalog number
18230
Device description
PQ-708 PIN DRIVER 2.6 - 4.0mm
Published
2022-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
05051471153684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051471153684050514711536845051471153684

GMDN Terms#

Term, Definition table
TermDefinition
Wire-driving power tool attachmentA 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 wire driving/insertion function when an appropriate orthopaedic wire is inserted, e.g., Kirschner wires or K-Wires (thin pins that are pointed for self-drilling). It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. The device may be of the micro or macro design. 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
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
05051471219519De Soutter MedicalS56-6652S56-66522026-06-24
05051471189201De Soutter MedicalP30-708P30-7082022-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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