Duns Number:242049828
Catalog Number
-
Brand Name
ST250
Version/Model Number
411101
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
KCW
Product Code Name
Epilator, High Frequency, Needle-Type
Public Device Record Key
ddd0d7d9-34a5-4880-81de-c571d43bf5be
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 24, 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 | 52 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |