ViziLite® 650101

GUDID D8136501010

VIZILITE EYEWARE

DEN-MAT HOLDINGS, LLC

Oral lesion examination light

• Primary Device ID: D8136501010
• NIH Device Record Key: d93e98dd-3ee6-4df8-b3b8-3624a5402791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViziLite®
• Version Model Number: 650101
• Catalog Number: 650101
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8136501010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080043

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ ViziLite®]

• D8136501991: VIZILITE PLUS TBULE EXAM 10 PACK
• D8136501060: TBLUE SUPPLEMENTL PK
• D8136501010: VIZILITE EYEWARE