KLYO - Single, Double and Triple M-Series LED Surgical - KLYO MEDICAL SYSTEMS INC.

Duns Number:058639417

Device Description: Single, Double and Triple M-Series LED Surgical Light system with and without Variable Col Single, Double and Triple M-Series LED Surgical Light system with and without Variable Color Temperature, for normal and Low Ceiling height installation and with or without wall controls.

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More Product Details

Catalog Number

-

Brand Name

KLYO

Version/Model Number

KLED-M

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)

-

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

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Device Record Status

Public Device Record Key

2f3c1801-b867-494f-97c5-403aee7802af

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

July 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KLYO MEDICAL SYSTEMS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1