FDA.reportPublic FDA data

JEDMED

Primary DI
M63339742920
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
39-7429-2
Catalog number
39-7429-2
Device description
CHIN REST PORTABLE
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

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M63339742920PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Camera control unitA mains electricity (AC-powered) unit intended to be used to remotely steer a camera's movements and adjustments (e.g., a miniaturized camera) in a clinical setting. It is typically situated outside the field of operation and can be adjusted upon instructions from the surgeon/operator, or it may be automated to a certain degree. Some remote control units may have extensive functions and may supply the camera with electric current and adjustments such as light intensity, colour control, automatic exposure, and automatic flash. Those types used in ophthalmology may operate the raise/lower function of the ophthalmic instrument table upon which the camera is situated.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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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