FDA.reportPublic FDA data

Urinary Catheter, 16 Fr

Primary DI
10854913006157
Brand
Urinary Catheter, 16 Fr
Company
UROGEN PHARMA LTD
Model
Urinary Catheter, 16 Fr, Coudé TiemannTip
Catalog number
UC0008
Device description
The Urinary Catheter is a single use 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long and made of biocompatible soft PVC and is uncoated.
Published
2025-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZCCatheter, Coude
KODCatheter, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZCCatheter, CoudeGastroenterology, Urology2
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211032000Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.2021-11-19KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20854913006154PackageGS130In Commercial Distribution
10854913006157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085491300615420854913006154
1085491300615710854913006157

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Catheter Length40Centimeter

Regulatory Flags#

DUNS number
534155213
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
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

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