Duns Number:827221698
Device Description: TheraTouch UX2 Stand Alone Ultrasound
Catalog Number
-
Brand Name
TheraTouch UX2
Version/Model Number
DQ2000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
d881d873-02d6-4a03-9b66-55e9409c2ed5
Public Version Date
September 15, 2022
Public Version Number
1
DI Record Publish Date
September 07, 2022
Package DI Number
80092237623813
Quantity per Package
2
Contains DI Package
00092237623817
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |