FDA.reportPublic FDA data

Cystoject Syringe Lever

Primary DI
20854913006048
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
20854913006048PackageGS11In 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00854913006044Cystoject Syringe LeverCystojectSL00042021-01-04
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
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
00854913006044Cystoject Syringe LeverUROGEN PHARMA LTDQBL2021-01-04
00854913006037Uroject12 Syringe LeverUROGEN PHARMA LTDQBL2019-02-11