Duns Number:481233849
Device Description: Swiss LithoClast Trilogy System Kit - US
Catalog Number
M006840200K0
Brand Name
LITHOCLAST
Version/Model Number
FT-235US
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
K182490,K173234,K181364,K181997
Product Code
FEO
Product Code Name
Lithotriptor, Ultrasonic
Public Device Record Key
e20fca8a-d65d-454b-9854-c89f02eaa58e
Public Version Date
November 06, 2018
Public Version Number
4
DI Record Publish Date
March 12, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| 3 | A medical device with high risk that requires premarket approval | 11 |