Duns Number:514905681
Device Description: STOP X MODEL STOP UPACKED GRADIENT RED USA
Catalog Number
34300010GR-US
Brand Name
STOP X
Version/Model Number
STOP U
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
K182774
Product Code
PAY
Product Code Name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Public Device Record Key
c58757ed-c904-4ef9-a1ab-b80f8798b813
Public Version Date
December 30, 2020
Public Version Number
1
DI Record Publish Date
December 22, 2020
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. | 19 |