ML 830® - Smart Laser DP - MICROLIGHT CORPORATION OF AMERICA

Duns Number:137829417

Device Description: Smart Laser DP

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More Product Details

Catalog Number

ML-830-07-100

Brand Name

ML 830®

Version/Model Number

ML-830-07-100

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K010175,K080786

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

c0a8cf3a-4ae2-4d31-a09f-3dcae305a3db

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROLIGHT CORPORATION OF AMERICA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27