Vision1

Basic Information

• Brand Name: Vision1
• Primary DI: 00724995209186
• Version / Model: VIS101
• Catalog Number: VIS101
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-10
• Public Version: 6
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 7278323e-8763-4453-a778-91089533d326

Device Description

The Vision1 Imaging Console and Display System is used exclusively with the Uretero1 Ureteroscope System.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGB	Ureteroscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56654	Endoscopic video image display unit	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995209186	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211347	000
K223466	000
K231878	000

Device Sizes

Type	Value	Unit	Text
Width	3	Centimeter
Length	230	Centimeter
Outer Diameter	2.4	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry