Duns Number:836416321
Device Description: The Terason 8V3A is a high-frequency, phase-array transducer. The intended uses include: f The Terason 8V3A is a high-frequency, phase-array transducer. The intended uses include: fetal, abdominal, pediatric, neonatal and adult cephalic, and adult and pediatric cardiac ultrasound imaging.
Catalog Number
-
Brand Name
Terason
Version/Model Number
8V3A
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)
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
95e64a1d-67e8-49a1-85a2-d1ce2ce72ba4
Public Version Date
December 21, 2018
Public Version Number
3
DI Record Publish Date
April 06, 2018
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. | 25 |