OnLite 7-1028B

GUDID 20816908010690

Vaginal Illuminator (Blue)

CYALUME TECHNOLOGIES, INC.

Vaginal illuminator Vaginal illuminator Vaginal illuminator

• Primary Device ID: 20816908010690
• NIH Device Record Key: fc927486-3820-4967-a520-0b4a3aa9c7de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnLite
• Version Model Number: 7-1028B
• Catalog Number: 7-1028B
• Company DUNS: 154779748
• Company Name: CYALUME TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: 1-888-733-4034
• Email: info@cyalumemed.com
• Phone: 1-888-733-4034
• Email: info@cyalumemed.com
• Phone: 1-888-733-4034
• Email: info@cyalumemed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816908010696 [Primary]
GS1	10816908010693 [Package]; Contains: 00816908010696; Package: Inner Pack [25 Units]; In Commercial Distribution
GS1	20816908010690 [Package]; Contains: 10816908010693; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• MPU: Source, Chemiluminescent Light

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-05

On-Brand Devices [OnLite]

• 20816908010690: Vaginal Illuminator (Blue)
• 20816908010683: Vaginal Illuminator (White)