Duns Number:005036025
Device Description: The Midmark 8' Dual Ceiling Mount LED Procedure Light is intended to be used in medical en The Midmark 8' Dual Ceiling Mount LED Procedure Light is intended to be used in medical environments where illumination is required for medical use during external examinations and procedures.
Catalog Number
255-023
Brand Name
Midmark
Version/Model Number
255-023
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
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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
KZF
Product Code Name
Device, medical examination, ac powered
Public Device Record Key
e41c0dd4-1848-49e8-bc02-a9ccc372261d
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
May 31, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |