AccessGUDID - DEVICE: OnLite (00816908010696)

GUDID

Device Identifier (DI) Information

Brand Name: OnLite
Version or Model: 7-1028B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7-1028B
Company Name: CYALUME TECHNOLOGIES, INC.

Primary DI Number: 00816908010696
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 154779748 *Terms of Use

Device Description: Vaginal Illuminator (Blue)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPU	Source, Chemiluminescent Light

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 40 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc927486-3820-4967-a520-0b4a3aa9c7de
Public Version Date: January 04, 2023
Public Version Number: 3
DI Record Publish Date: April 05, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20816908010690	10	10816908010693	2023-01-01	Not in Commercial Distribution	Case
10816908010693	25	00816908010696	2023-01-01	Not in Commercial Distribution	Inner Pack