Duns Number:827221698
Device Description: TheraSonic Conductive Gel, 2-o
Catalog Number
-
Brand Name
N/A
Version/Model Number
LC2828
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"
Yes
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
780ab258-c3ed-44c9-8584-9622b2007c42
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 13, 2016
Package DI Number
80092237613241
Quantity per Package
72
Contains DI Package
00092237613245
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
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 |