Duns Number:007198742
Catalog Number
-
Brand Name
9 French Electrohydraulic Lithotriptor Probe
Version/Model Number
E4-9F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2021
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
Yes
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
FFK
Product Code Name
Lithotriptor, electro-hydraulic
Public Device Record Key
18a9f0c3-64c2-4f31-8907-347b3937f81f
Public Version Date
October 12, 2022
Public Version Number
4
DI Record Publish Date
October 05, 2016
Package DI Number
00821925002449
Quantity per Package
3
Contains DI Package
00821925040236
Package Discontinue Date
June 04, 2021
Package Status
Not 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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |