AccessGUDID - DEVICE: Ultra Violet Mini Light (D798UVML0)

GUDID

Device Identifier (DI) Information

Brand Name: Ultra Violet Mini Light
Version or Model: UVML
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UVML
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798UVML0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Ultra Violet Mini Light is used to fluoresce materials that contain fluorescing agents

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:	No
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?
35736	Ultraviolet view box	A mains electricity (AC-powered) device designed for visual examination of a process and/or its results using ultraviolet (UV) light. It is used to support and illuminate an object with UV light so that the information held within this object can be seen and studied. It typically includes UV lamps of one or more frequencies (254, 312, and 366 nm are typical), a translucent diffusing screen, and filters; the illumination typically comes from behind the object being viewed. It is mainly used in clinical laboratories for visual examination of a process and/or its results (e.g., for assessing thin-layer chromatographs, electrophoresis gels); but is also used in photo documentation processes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECP	Instrument, Ligature Tucking, Orthodontic

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
Special Storage Condition, Specify: Store at ambient conditions

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e836b68-d29f-4be6-a6b0-3fbc3f13457d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 25, 2016