Midmark - The Wall Mounted Dental LED Light is intended to - MIDMARK CORPORATION

Duns Number:005036025

Device Description: The Wall Mounted Dental LED Light is intended to be used as a component in a dental enviro The Wall Mounted Dental LED Light is intended to be used as a component in a dental environment to provide lighting during dental procedures.

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More Product Details

Catalog Number

WAML

Brand Name

Midmark

Version/Model Number

WAML

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

EAZ

Product Code Name

LIGHT, OPERATING, DENTAL

Device Record Status

Public Device Record Key

298abf41-189b-4211-81cb-9b369efd8f14

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

May 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIDMARK CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 838
2 A medical device with a moderate to high risk that requires special controls. 544