FDA.report

JEDMED

Primary DI
M6333104600
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
31-0460
Catalog number
31-0460
Device description
HOOK & SPOON GROSS
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JYLHook, Microsurgical Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M6333104600PrimaryHIBCC0

GMDN Terms

TermDefinition
Incus hookA shaft-like, hand-held manual surgical instrument intended to be used during ear/nose/throat (ENT) surgery for fixation or traction of the incus bone (the anvil bone of the group of three that form the sound-transmitting ossicles in the middle ear). The device tapers towards the distal end to form a hook or multiple hooks used in the procedure. The proximal end forms a handle which may vary in shape. In multiple hook designs, the hooks are in parallel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
092987189
Device count
1
DM exempt
true
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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