AccessGUDID - DEVICE: 4K UHD Camera System (06971381250060)

GUDID

Device Identifier (DI) Information

Brand Name: 4K UHD Camera System
Version or Model: ES-CS4K100/100C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06971381250060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544519831 *Terms of Use

Device Description: The product is composed of a 4K camera control unit, a 4K camera head, objective lens, a power cable, and video cables. Video cables contains: HD-SDI cable, HDMI cable. HD-SDI cable, HDMI cable and objective lens are optional. 4K UHD Camera System is mainly used to provide imaging of the operative area in endoscopic surgery. Do not use this system for any other purpose.

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:	No
Prescription Use (Rx):	Yes
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?
18034	Endoscopic video image processing unit	An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	Laparoscope, Gynecologic (And Accessories)
FGB	Ureteroscope And Accessories, Flexible/Rigid
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
NWB	Endoscope, Accessories, Narrow Band Spectrum
EOB	Nasopharyngoscope (Flexible Or Rigid)
GCJ	Laparoscope, General & Plastic Surgery
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200216	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 28 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1367c3f-43ab-4810-9ac8-3c83b90af5b5
Public Version Date: April 14, 2025
Public Version Number: 3
DI Record Publish Date: May 17, 2023