Duns Number:002044410
Device Description: Two 4-Watt Integrally Filtered UV-A Tubes and Two 4-Watt White Light Tube. Woods Lamps. Th Two 4-Watt Integrally Filtered UV-A Tubes and Two 4-Watt White Light Tube. Woods Lamps. These lamps feature an extra-lightweight ballast and housing design, for fatigue-free use. Rugged fixed handles and heavy-duty power cords with strain reliefs ensure added durability.
Catalog Number
102
Brand Name
Spectroline
Version/Model Number
Q-22
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
FTC
Product Code Name
Light, Ultraviolet, Dermatological
Public Device Record Key
1c2193a4-4b06-4694-8d37-8b7ef0631d14
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |