FDA.reportPublic FDA data

Cystoject Syringe Lever

Primary DI
00854913006044
Brand
Cystoject Syringe Lever
Company
UROGEN PHARMA LTD
Model
Cystoject
Catalog number
SL0004
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.
Published
2021-01-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QBLPiston Syringe Lever

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBLPiston Syringe LeverGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203321000Cystoject Syringe LeverUrogen Pharma, Ltd.2020-12-09QBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20854913006048PackageGS11Not in Commercial Distribution
00854913006044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085491300604820854913006048
00854913006044008549130060448549130060440854913006044

GMDN Terms#

Term, Definition table
TermDefinition
Syringe dispensing screw-pressA 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.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant""]"

Regulatory Flags#

DUNS number
534155213
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854913006201Intravesical Administration Kit IVAK3000252026-03-15
10854913006188Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00112025-11-17
10854913006195Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé Olive TipUC00102025-11-17
20854913006185Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00112025-11-17
20854913006192Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé Olive TipUC00102025-11-17
10854913006157Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé TiemannTipUC00082025-11-16
10854913006164Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00092025-11-16
20854913006154Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé TiemannTipUC00082025-11-16
20854913006161Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00092025-11-16
10854913006171Intravesical Administration KitIVAK3000062025-06-16
10854913006096Ureteral Catheter Administration KitUCAK2000062020-05-17
10854913006119Urinary CatheterUrinary Catheter, 12 FrUC00052022-06-01
20854913006116Urinary CatheterUrinary Catheter, 12 FrUC00052022-06-01
10854913006126Urinary CatheterUrinary Catheter, 16 FrUC00062022-06-01
10854913006140Chilling Block 2 syringes + 3 vialsUCB00022022-02-03
10854913006089Chilling Block 2 syringes + 2 vials2019-03-13
20854913006048Cystoject Syringe LeverCystojectSL00042021-01-04
00854913006037Uroject12 Syringe LeverUroject12SL00022019-02-11
108549130060587 Fr. Ureteral catheter Ureteral catheter2019-02-11
10854913006072Chilling Block 2 syringes + 3 vials2019-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20854913006048Cystoject Syringe LeverUROGEN PHARMA LTDQBL2021-01-04
00854913006037Uroject12 Syringe LeverUROGEN PHARMA LTDQBL2019-02-11