FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471123809
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
K92-144
Catalog number
K92-144
Device description
K-WIRE - DOUBLE TROCAR 1.4mm DIA x 100mm
Published
2022-11-24
Public version status
Update
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
15051471123806PackageGS15In Commercial Distribution
05051471123809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147112380615051471123806
05051471123809050514711238095051471123809

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. 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
05051471223875De Soutter MedicalS89-9535S89-95352026-06-03
05051471223639De Soutter MedicalS86-1585S86-15852026-06-01
05051471221512De Soutter MedicalT20-122T20-1222026-05-27
05051471221697De Soutter Medical21640216402026-05-27
05051471221703De Soutter Medical21650216502026-05-27
05051471221710De Soutter Medical21660216602026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00193982678975VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678999VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679064VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679088VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679101VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679125VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679149VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679163VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679248VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679262VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679309VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679323VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679347VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHGEY2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHGEY2025-12-18
J021304670001S-9 ES RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
J021304680001S-10 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
J021304700001S-12 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
10845854035009ADVANTAGEConmed CorporationGEY2023-12-04
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHGEY2023-10-12