High CRI LED Light Source - High CRI LED Light Source - VITALCOR, INC

Duns Number:020942546

Device Description: High CRI LED Light Source

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More Product Details

Catalog Number

847400

Brand Name

High CRI LED Light Source

Version/Model Number

847400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

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

NTN

Product Code Name

Led light source

Device Record Status

Public Device Record Key

217eca94-eb86-4c0d-b03e-d642b97bfd4d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITALCOR, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19