Duns Number:557793906
Catalog Number
-
Brand Name
Hansol Medical Co.
Version/Model Number
HANSOL Cupping Set(19PCS)
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
KNM
Product Code Name
Device, Pressure Applying
Public Device Record Key
cce6becf-d228-4ea3-ae6d-8b7146eaedc0
Public Version Date
April 23, 2020
Public Version Number
3
DI Record Publish Date
February 11, 2019
Package DI Number
18809118710011
Quantity per Package
10
Contains DI Package
08809118710014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |