Duns Number:534155213
Device Description: The Cystoject Syringe Lever is a reusable device that is intended to assist in the delive The Cystoject Syringe Lever is a reusable device that is intended to assist in the delivery of fluids from a standard 30 mL syringe during urinary tract procedures. The Cystoject Syringe Lever body contains a syringe housing for holding a standard syringe and a dispensing mechanism that is manually operated by rotating a knob and presses the syringe piston. A clutch mechanism facilitates fast adaptation of the dispensing mechanism to the syringe piston position. The Cystoject Syringe Lever is to be sterilized before use and cleaned after use.
Catalog Number
SL0004
Brand Name
Cystoject Syringe Lever
Version/Model Number
Cystoject
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
K203321,K203321
Product Code
QBL
Product Code Name
Piston Syringe Lever
Public Device Record Key
4663db7b-dec6-4196-82c8-0901371f21c5
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
Package DI Number
20854913006048
Quantity per Package
1
Contains DI Package
00854913006044
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |