FDA.reportPublic FDA data

gSource

Primary DI
00840314230638
Brand
gSource
Company
GSOURCE LLC
Model
gS 56.1530
Catalog number
gS 56.1530
Device description
"Alexander Gouge 7"" str 10mm"
Published
2020-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840314230638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314230638008403142306388403142306380840314230638

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

Regulatory Flags#

DUNS number
008162518
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
00840314243782gSourcegS 82.4740gS 82.47402020-02-27
00840314220448gSourcegS 42.7171gS 42.71712019-12-27
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314222237gSourcegS 45.5033gS 45.50332020-01-02
00840314222244gSourcegS 45.5043gS 45.50432020-01-02
00840314222251gSourcegS 45.5060gS 45.50602020-01-02
00840314231598gSourcegS 59.7670gS 59.76702020-02-14
00840314242723gSourcegS 81.3716gS 81.37162020-02-26
00840314242730gSourcegS 81.3717gS 81.37172020-02-26
00840314233073gSourcegS 65.7440gS 65.74402020-02-18
00840314243874gSourcegS 82.4870gS 82.48702020-02-27
00840314246295gSourcegS 86.4420gS 86.44202020-03-03
00840314246349gSourcegS 86.4530gS 86.45302020-03-03
00840314221278gSourcegS 43.4120gS 43.41202019-12-31
00840314270344gSourcegS 40.1143gS 40.11432026-09-22
00840314269744gSourcegS 59.1800gS 59.18002025-05-05
00840314269690gSourcegS 49.2400gS 49.24002025-01-15
00840314269652gSourcegS 47.6299gS 47.62992024-10-25
00840314269638gSourcegS 82.8035gS 82.80352024-10-15
00840314269591gSourcegS 47.6050gS 47.60502024-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407544MillenniumAvalign Technologies, Inc.GDH2026-08-03
00190776407353MillenniumAvalign Technologies, Inc.GDH2026-07-28
B7685674460Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2026-04-24
B7685676080Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2026-04-24
B7685677060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2026-04-24
B7685676050Buxton BiomedicalBUXTON BIOMEDICAL, INC.GDH2023-12-08
B7685674210Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2023-06-16
B7687720200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2023-05-26
B7687722250Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2023-05-26
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
04038653109999AESCULAPAesculap AGGDH2020-05-08
04038653110018AESCULAPAesculap AGGDH2020-05-08
04038653110056AESCULAPAesculap AGGDH2020-05-06
10603295083375SIGMADEPUY (IRELAND)GDH2018-09-24
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