Duns Number:053947946
Device Description: Exam Light, Lumerus LED Flex Neck, 12-24V DC G2
Catalog Number
130-2011
Brand Name
MTI
Version/Model Number
130-2011
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"
-
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
7ec44bd2-4965-4bd9-88f8-b8a6c85c09c8
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
February 03, 2020
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 | 300 |