VELscope 4662

GUDID 07540201000049

LED Dental Inc

Medical equipment handle cover, single-use, non-sterile

• Primary Device ID: 07540201000049
• NIH Device Record Key: 89e79e1e-0a79-4e07-9099-63ce266eb91b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VELscope
• Version Model Number: VELscope Vx Value Bundle-US
• Catalog Number: 4662
• Company DUNS: 243167546
• Company Name: LED Dental Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540201000049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102083

FDA Product Code

• NXV: Diagnostic Light, Soft Tissue Detector

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-06
• Device Publish Date: 2016-09-24

On-Brand Devices [VELscope]

• 00754020100096: VELscope Vx Value Bundle-Basic
• 00754020100041: VELscope Vx Value Bundle-US
• 00754020100010: VELscope Vx
• 07540201000094: VELscope Vx Value Bundle-Basic
• 07540201000049: VELscope Vx Value Bundle-US
• 27540201000036: VELsheath Vx
• 07540201000025: VELcap Vx
• 07540201000018: VELscope Vx