AccessGUDID - DEVICE: NA (10886705026180)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 242300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 242300
Company Name: Medos International Sàrl

Primary DI Number: 10886705026180
Issuing Agency: GS1
Commercial Distribution End Date: January 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: OVB1 HD Camera Control Unit Contents also include: (1) Power Cable, (1) USB Flash Drive, (1) Video Cable DVI-D to DVI-D, 1m, (1) Video Cable DVI-D to DVI-D, 3m, (1) Video Cable HD SDI, 12 ft, (2) Remote Cable, 3.5mm, 3 ft

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
FWF	CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO

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
Special Storage Condition, Specify: Waste Electrical and Electronic Equipment
Handling Environment Temperature: between 14 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Temperature: between 14 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 877a89ea-b0d3-44e0-9963-91134c40bcb1
Public Version Date: January 28, 2021
Public Version Number: 6
DI Record Publish Date: January 30, 2016