FDA UDI
In Commercial Distribution
🇺🇸 United States
Cystoject Syringe Lever
DI: 00854913006044
·
Model: Cystoject
·
UROGEN PHARMA LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cystoject Syringe Lever
- Primary DI
- 00854913006044
- Version / Model
- Cystoject
- Catalog Number
- SL0004
- Company Name
- UROGEN PHARMA LTD
- Labeler DUNS
- 534155213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-04
- Public Version
- 1
- Public Version Date
- 2021-01-12
- Public Version Status
- New
- Public Device Record Key
- 4663db7b-dec6-4196-82c8-0901371f21c5
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QBL | Piston Syringe Lever | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64107 | Syringe dispensing screw-press | A hand-held, manually-operated device intended to facilitate the infusion/dispensing of a high viscosity liquid (e.g., anaesthetic agent, antiretropulsion gel) from a syringe by assisting with the advancement of the syringe plunger. It includes a barrel-like component which houses the syringe, and a piston which compresses the syringe plunger via a rotating-screw mechanism operated (by turning a wheel/knob) by the user. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20854913006048 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00854913006044 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203321 | 000 |