FDA.reportPublic FDA data

Self-Cath

Primary DI
05701780228237
Brand
Self-Cath
Company
Coloplast A/S
Model
50182 / 114
Catalog number
50182 / 114
Device description
Self-Cath®. Urinary Catheter. Soft Straight Tip Male. Catheter Gauge 14 FR/CH, Diameter 4.7 mm.
Published
2021-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZDCATHETER, STRAIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100878000SELF CATH CATHETERColoplast Manufacturing Us, LLC2010-05-26EZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05701780228237PackageGS130In Commercial Distribution
05701780228244PackageGS112In Commercial Distribution
05701780228220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05701780228237057017802282375701780228237
05701780228244057017802282445701780228244
05701780228220057017802282205701780228220

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 Gauge14French
Catheter Working Length14.9Inch
Catheter Working Length38Centimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged and consult IFU.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30

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Primary DI, Brand, Company table
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10704411008859AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
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10704411008880AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02