futudent

Primary DI
06429810664006
Brand
futudent
Company
Novocam Medical Innovations Oy
Model
smartCam
Catalog number
SMCS
Device description
These apparatuses are intended by the manufacturer to be used by qualified healthcare professionals to capture videos and pictures during dental and medical treatments for the purpose of documentation, providing additional information for diagnosis, following and evaluating changes of medical conditions and for educational purposes in dent
Published
2023-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06429810664006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06429810664006064298106640066429810664006

GMDN Terms#

Term, Definition table
TermDefinition
Surgical video cameraAn electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight50Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
539845795
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06429810664013futudentproCam XSPRCX2023-09-04
06429810664020futudentmicroCam XSMCCX2023-09-04
06429810664037futudentproCamPRCG2023-09-04
06429810664044futudenteduCamEDUS2023-09-04
06429810664051futudentscopeCamCMPX2023-09-04

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