Duns Number:134614411
Device Description: For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers
Catalog Number
644-081
Brand Name
EX3 Stepper
Version/Model Number
644-081
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
K131161,K131161
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
09e56a87-9d37-41c5-84c1-bf6650f3e88e
Public Version Date
September 06, 2021
Public Version Number
5
DI Record Publish Date
August 22, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |