FDA.report

JEDMED

Primary DI
M6335143910
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
51-4391
Catalog number
51-4391
Device description
GOUGE PARKES DOUBLE GUARD
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KAQGouge, Nasal, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KAQGouge, Nasal, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M6335143910PrimaryHIBCC0

GMDN Terms

TermDefinition
Nasal gougeA single-bladed, hand-held manual surgical instrument designed to cut and shape the bone and cartilage of the nose during ear/nose/throat (ENT) surgery. 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 typically made of high-grade stainless steel as a one-piece instrument and 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. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
092987189
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M6332904600JEDMED29-046029-04602022-12-19
M6335824200JEDMED58-242058-24202023-01-19
M6334942100JEDMED49-421049-42102016-12-14
M6334942130JEDMED49-421349-42132016-12-14
M6334942170JEDMED49-421749-42172016-12-14
M6334942200JEDMED49-422049-42202016-12-14
M6334942230JEDMED49-422349-42232016-12-14
M6334942270JEDMED49-422749-42272016-12-14
M6334943000JEDMED49-430049-43002016-12-14
M6334943030JEDMED49-430349-43032016-12-14
M633494303A0JEDMED49-4303 A49-4303 A2016-12-14
M6334943040JEDMED49-430449-43042016-12-14
M6334943070JEDMED49-430749-43072016-12-14
M6334943100JEDMED49-431049-43102016-12-14
M633494310W0JEDMED49-4310 W49-4310 W2016-12-14
M6334943130JEDMED49-431349-43132016-12-14
M633494313A0JEDMED49-4313 A49-4313 A2016-12-14
M633494313W0JEDMED49-4313 W 49-4313 W2016-12-14
M6334943170JEDMED49-431749-43172016-12-14
M6334944100JEDMED49-441049-44102016-12-14

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