VELscope 5720

GUDID 27540201000036

LED Dental Inc

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

• Primary Device ID: 27540201000036
• NIH Device Record Key: e4c642fe-e266-43f9-9c36-45ebceae9dee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VELscope
• Version Model Number: VELsheath Vx
• Catalog Number: 5720
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	07540201000032 [Primary]
GS1	17540201000039 [Package]; Contains: 07540201000032; Package: Dispenser Box-250 [250 Units]; In Commercial Distribution
GS1	27540201000036 [Package]; Contains: 17540201000039; Package: Master Carton-3000 [12 Units]; In Commercial Distribution

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