Duns Number:689372738
Device Description: The jet gun sprays water and pressurized air to perform fine exfoliation, removing dead sk The jet gun sprays water and pressurized air to perform fine exfoliation, removing dead skin cell, while the spray handpiece sprays fine particles of solution, helping the solution to penetrate deep into the skin.
Catalog Number
-
Brand Name
JET CLEAR
Version/Model Number
ESM-3000MO
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"
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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
GFE
Product Code Name
Brush, Dermabrasion, Powered
Public Device Record Key
22988ee6-ac3f-4bc2-8c5e-a016e1d028d3
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 2022
Package DI Number
18800060501672
Quantity per Package
1
Contains DI Package
08800060501675
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PALLET
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |