futudent

Basic Information

• Brand Name: futudent
• Primary DI: 06429810664006
• Version / Model: smartCam
• Catalog Number: SMCS
• Company Name: Novocam Medical Innovations Oy
• Labeler DUNS: 539845795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-04
• Public Version: 1
• Public Version Date: 2023-09-12
• Public Version Status: New
• Public Device Record Key: 5ad8c674-daaf-4fb8-80aa-774a24a8f79c

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32265	Surgical video camera	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06429810664006	GS1

Device Sizes

Type	Value	Unit	Text
Weight	50	Gram

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity