Duns Number:134614411
Device Description: For use with BK Medical 8658(8558), 8848 and E14CL4b transducers
Catalog Number
620-089
Brand Name
Classic Stepper
Version/Model Number
620-089
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
4823ec81-e9fa-40fd-9f86-12341b48092f
Public Version Date
September 24, 2018
Public Version Number
4
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 |