FDA.reportPublic FDA data

GOUGE

Primary DI
00888118026729
Brand
GOUGE
Company
KLS-Martin L.P.
Model
23-109-02-07
Device description
PARTSCH, 2 MM TIP
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00888118026729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118026729008881180267298881180267290888118026729

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24
00888118035882LEVEL ONE NEURO25-015-04-092016-03-24
00888118035912LEVEL ONE NEURO25-015-06-092016-03-24
00888118035943LEVEL ONE NEURO25-015-08-092016-03-24
00888118035974LEVEL ONE NEURO25-016-06-092016-03-24
00888118036018LEVEL ONE NEURO25-016-10-092016-03-24
00888118036049LEVEL ONE CMF25-017-04-092016-03-24
00888118036056LEVEL ONE CMF25-017-06-092016-03-24
00888118036063LEVEL ONE CMF25-017-08-092016-03-24
00888118036148LEVEL ONE CMF25-020-24-092016-03-24

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Primary DI, Brand, Company table
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07898506848324QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506850259QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848256QuinelatoSchobell Industrial LtdaGDH2022-12-16
07898506848263QuinelatoSchobell Industrial LtdaGDH2022-12-16
10603295083375SIGMADEPUY (IRELAND)GDH2018-09-24
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10381780405603Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
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10649111030956Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031045Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031939Sklar®SKLAR CORPORATIONGDH2018-04-23
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