Duns Number:330961223
Device Description: Hospital Device
Catalog Number
-
Brand Name
TruLight
Version/Model Number
4038130
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 17, 2016
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
FQP
Product Code Name
Lamp, operating-room
Public Device Record Key
0973e0e1-8742-4390-b424-06e9ce279d18
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
September 17, 2016
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 | 624 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |