Duns Number:315304071
Device Description: OPT.STONE GRASP.FORCEPS CVD. DOWNWARDS double-action, for grasping and crushing small cal OPT.STONE GRASP.FORCEPS CVD. DOWNWARDS double-action, for grasping and crushing small calculi, for sheaths from 23Fr, for telescope 0° Ø 4mm, with twist lock, reusable
Catalog Number
8650.664
Brand Name
NA
Version/Model Number
8650664
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FFL
Product Code Name
DISLODGER, STONE, BASKET, URETERAL, METAL
Public Device Record Key
8af9d753-16e7-4a43-9d2d-c4e018931d63
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |