Duns Number:004238200
Device Description: Light Based Over-The-Counter Hair Removal
Catalog Number
-
Brand Name
Braun Silk Expert 5
Version/Model Number
BD5004
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHT
Product Code Name
Light Based Over-The-Counter Hair Removal
Public Device Record Key
4b4a0898-0da4-4001-bd57-a92bc6de9a44
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
December 21, 2018
Package DI Number
10069055886196
Quantity per Package
2
Contains DI Package
00069055886199
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 241 |
U | Unclassified | 1 |