VELscope

Basic Information

• Brand Name: VELscope
• Primary DI: 07540201000032
• Version / Model: VELsheath Vx
• Catalog Number: 5720
• Company Name: LED Dental Inc
• Labeler DUNS: 243167546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2019-12-06
• Public Version Status: Update
• Public Device Record Key: e4c642fe-e266-43f9-9c36-45ebceae9dee

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: No
• 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: 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
NXV	Diagnostic Light, Soft Tissue Detector	Dental	872.6350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17977	Medical equipment handle cover, single-use, non-sterile	A non-sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., examination/treatment light) to provide a hygienic barrier between the handle and the hand of a healthcare professional. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27540201000036	GS1	Master Carton-3000	12	In Commercial Distribution
Package	17540201000039	GS1	Dispenser Box-250	250	In Commercial Distribution
Primary	07540201000032	GS1

Premarket Submissions

Submission Number	Supplement Number
K102083	000