FDA.report

JEDMED

Primary DI
M6337101040
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
71-0104
Catalog number
71-0104
Device description
OBJECTIVE V-SERIES F=200MM
Published
2023-02-06
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
EPTMicroscope, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M6337101040PrimaryHIBCC0

GMDN Terms

TermDefinition
ENT surgical microscopeA light (optical) magnification instrument designed to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. It typically consists of a stereo microscope (standard or modified) and a mobile floor stand or wall or ceiling mount. It is usually held by an adjustable arm attached to the support mechanism and equipped with motorized focusing, adjustable magnification systems (manual, zoom, or both), backup lamps, and inclined tubes. Dual- or multiple-observation capability and the optical integration of still, motion picture, and TV cameras are common features.

Sterilization Methods

Method

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
false

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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