NA

Basic Information

• Brand Name: NA
• Primary DI: 10886705026180
• Version / Model: 242300
• Catalog Number: 242300
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-30
• Public Version: 6
• Public Version Date: 2021-01-28
• Public Version Status: Update
• Public Device Record Key: 877a89ea-b0d3-44e0-9963-91134c40bcb1
• Distribution End Date: 2021-01-28

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

• Single Use: No
• Prescription Use (Rx): Yes
• 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
FWF	CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886705026180	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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