Duns Number:002692106
Device Description: Suntan Booth. Four connected panels, attached to wall, wrap around person. 20 suntan lamps Suntan Booth. Four connected panels, attached to wall, wrap around person. 20 suntan lamps, each 72" in height.
Catalog Number
2000HT
Brand Name
Peacock Tanning
Version/Model Number
2000HT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LEJ
Product Code Name
Booth, Sun Tan
Public Device Record Key
064fa656-365b-46c6-9226-6e59b527f099
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 09, 2017
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. | 21 |
| U | Unclassified | 3 |