FDA.reportPublic FDA data

JEDMED

Primary DI
M6333974410
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
39-7441
Catalog number
39-7441
Device description
HANGER KIT F/HORUS SCOPE (f/ otoscope only)
Published
2022-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FXRHolder, Camera, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXRHolder, Camera, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6333974410PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directAn electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03
M6339977120JEDMED99-771299-77122023-02-03
M6339977400JEDMED99-774099-77402023-02-03
M6339977410JEDMED99-774199-77412023-02-03
M6339977420JEDMED99-774299-77422023-02-03
M6339977430JEDMED99-774399-77432023-02-03
M6339977450JEDMED99-774599-77452023-02-03
M6339977460JEDMED99-774699-77462023-02-03
M63399774610JEDMED99-7746-199-7746-12023-02-03
M6339977470JEDMED99-774799-77472023-02-03
M6339977480JEDMED99-774899-77482023-02-03
M6339977490JEDMED99-774999-77492023-02-03
M6339977500JEDMED99-775099-77502023-02-03
M6339978000JEDMED99-780099-78002023-02-03
M6339978100JEDMED99-781099-78102023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867514263Arthrex®ARTHREX, INC.FXR2026-01-26
03700712414283Maquet EquipmentMAQUET SASFXR2025-01-06
03700712414290Maquet EquipmentMAQUET SASFXR2025-01-06
03700712414306Maquet EquipmentMAQUET SASFXR2025-01-06
03700712421403Maquet EquipmentMAQUET SASFXR2024-03-05
03700712422455Maquet EquipmentMAQUET SASFXR2024-03-05
03700712422462Maquet EquipmentMAQUET SASFXR2024-03-05
03700712432935Maquet EquipmentMAQUET SASFXR2023-12-15
03700712421410Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421427Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421434Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421441Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421458Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421465Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421472Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421489Maquet EquipmentMAQUET SASFXR2023-07-03
03700712421496Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422240Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422257Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422264Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422271Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422288Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422295Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422301Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422318Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422325Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422332Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422349Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422356Maquet EquipmentMAQUET SASFXR2023-07-03
03700712422363Maquet EquipmentMAQUET SASFXR2023-07-03