AccessGUDID - DEVICE: futudent (06429810664044)

GUDID

Device Identifier (DI) Information

Brand Name: futudent
Version or Model: eduCam
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EDUS
Company Name: Novocam Medical Innovations Oy

Primary DI Number: 06429810664044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 539845795 *Terms of Use

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 dental and medical field.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQM	Camera, Surgical And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 50 Degrees Celsius
Handling Environment Humidity: less than 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 23 Gram

Device Record Status

Public Device Record Key: 9aa37789-8bad-4b74-80be-e05e051e689b
Public Version Date: September 12, 2023
Public Version Number: 1
DI Record Publish Date: September 04, 2023