Duns Number:675938472
Catalog Number
-
Brand Name
Johari Digital Healthcare Limited
Version/Model Number
JUS2
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
IMG
Product Code Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Public Device Record Key
0a39d118-0941-4a55-83a5-e8697a1cfd23
Public Version Date
December 27, 2021
Public Version Number
4
DI Record Publish Date
September 19, 2016
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. | 41 |
3 | A medical device with high risk that requires premarket approval | 1 |