VS3 Visionsense Stereoscopic High Definition (3DHD) Vision System

Basic Information

• Brand Name: VS3 Visionsense Stereoscopic High Definition (3DHD) Vision System
• Primary DI: 18130400103014
• Version / Model: VS3-NE
• Catalog Number: 143-0001
• Company Name: VISIONSENSE LTD.
• Labeler DUNS: 532199478
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2022-02-16
• Public Version Status: Update
• Public Device Record Key: 4931aead-2fe7-46ba-b24c-c8dda1abce8d
• Distribution End Date: 2022-02-15

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
GWG	Endoscope, Neurological	Neurology	882.1480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35958	Endoscope video camera	An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. 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	18130400103014	GS1