AccessGUDID - DEVICE: Sunoptic Technologies (M678DLS0)

GUDID

Device Identifier (DI) Information

Brand Name: Sunoptic Technologies
Version or Model: Rover Lightsource series
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SUNOPTIC TECHNOLOGIES LLC

Primary DI Number: M678DLS0
Issuing Agency: HIBCC
Commercial Distribution End Date: August 13, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 094586898 *Terms of Use

Device Description: LED Rover Disoposable Series

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?
38832	Hand-held examination/treatment light	A small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCW	Light Source, Fiberoptic, Routine

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a1daf3f-5011-4b74-9e5b-89532aecc3c2
Public Version Date: August 14, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2018