Duns Number:481233849
Device Description: Stone catcher - sterile
Catalog Number
M0068407500
Brand Name
LithoClast
Version/Model Number
DT-059
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2017
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
K963285,K963285
Product Code
FFK
Product Code Name
Lithotriptor, Electro-Hydraulic
Public Device Record Key
d5a4c0ec-0029-402c-8630-3473f4627f2f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
07613353000349
Quantity per Package
5
Contains DI Package
07613353000332
Package Discontinue Date
June 30, 2017
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 | 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 |