OnLite

Basic Information

• Brand Name: OnLite
• Primary DI: 00816908010689
• Version / Model: 7-1028W
• Catalog Number: 7-1028W
• Company Name: CYALUME TECHNOLOGIES, INC.
• Labeler DUNS: 154779748
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-05
• Public Version: 3
• Public Version Date: 2023-01-04
• Public Version Status: Update
• Public Device Record Key: c84440e6-6408-4957-a7df-905bc82b4eda
• Distribution End Date: 2023-01-01

Device Description

Vaginal Illuminator (White)

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MPU	Source, Chemiluminescent Light	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46960	Vaginal illuminator	A device used to illuminate the vagina during a gynaecological examination or procedure. It is typically a chemiluminescent illumination source that is attached to the upper dilator blade of a vaginal speculum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20816908010683	GS1	Case	10	Not in Commercial Distribution	2023-01-01
Package	10816908010686	GS1	Inner Pack	25	Not in Commercial Distribution	2023-01-01
Primary	00816908010689	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 90 Degrees Fahrenheit