Ultra Violet Mini Light - Ultra Violet Mini Light is used to fluoresce - RELIANCE ORTHODONTIC PRODUCTS INC

Duns Number:113170088

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

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More Product Details

Catalog Number

UVML

Brand Name

Ultra Violet Mini Light

Version/Model Number

UVML

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ECP

Product Code Name

Instrument, Ligature Tucking, Orthodontic

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RELIANCE ORTHODONTIC PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 73
2 A medical device with a moderate to high risk that requires special controls. 279