FDA.reportPublic FDA data

SIGMA

Primary DI
10603295083375
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
2024-57-000
Catalog number
202457000
Device description
SIGMA HP PARTIAL KNEE-UNI FEMORAL TIP GOUGE
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295083375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329508337510603295083375

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24
10603295080145NA2001-80-5012001805012018-09-24
10603295080770NA2002-25-0002002250002018-09-24
10603295080787NA2002-27-0002002270002018-09-24
10603295080794NA2002-31-0002002310002018-09-24
10603295082057TRI-LOCK2012-03-0052012030052018-09-24
10603295082064TRI-LOCK2012-03-0102012030102018-09-24
10603295082071TRI-LOCK2012-03-0202012030202018-09-24
10603295082088TRI-LOCK2012-03-0302012030302018-09-24
10603295082095TRI-LOCK2012-03-0402012030402018-09-24
10603295082101TRI-LOCK2012-03-0502012030502018-09-24
10603295082118TRI-LOCK2012-03-0602012030602018-09-24
10603295082125TRI-LOCK2012-03-0702012030702018-09-24
10603295082132TRI-LOCK2012-03-0802012030802018-09-24
10603295082149TRI-LOCK2012-03-0902012030902018-09-24
10603295082156TRI-LOCK2012-03-1002012031002018-09-24
10603295082163TRI-LOCK2012-03-1102012031102018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898506847549QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848232QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848249QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848287QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848294QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848317QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848324QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506850259QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848256QuinelatoSchobell Industrial LtdaGDH2022-12-16
07898506848263QuinelatoSchobell Industrial LtdaGDH2022-12-16
10381780184584Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780184607Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780221128Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780363071Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780405603Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780403357Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403364Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403371Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403388Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403425Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403432Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780405689Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780406983Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780408598Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10649111030956Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031045Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031939Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111037474Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111037610Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111037948Sklar®SKLAR CORPORATIONGDH2018-04-23