FDA.reportPublic FDA data

Cure Catheter®

Primary DI
20815947020196
Brand
Cure Catheter®
Company
CURE MEDICAL LLC
Model
F10
Device description
Sterile Intermittent Urinary Catheter with Funnel End, Straight Tip
Published
2016-09-24
Public version status
Update
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
K072539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072539000CURE CATHETERCure Medical, LLC2007-09-13EZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815947020199PackageGS130In Commercial Distribution
20815947020196PackageGS110In Commercial Distribution
00815947020192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081594702019910815947020199
2081594702019620815947020196
00815947020192008159470201928159470201920815947020192

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 Gauge10French
Length6Inch
Length15Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
070643426
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
10815947021257Cure DextraDEX142020-08-28
10815947021264Cure DextraDEX162020-08-28
10815947021271Cure DextraDEX182020-08-28
10815947020465Cure Medical Catheter Insertion KitK12016-09-24
20815947020011Cure Catheter®M102016-09-24
20815947020028Cure Catheter®M122016-09-24
20815947020035Cure Catheter®M142016-09-24
20815947020042Cure Catheter®M162016-09-24
20815947020059Cure Catheter®M182016-09-24
20815947020066Cure Catheter®M10C2016-09-24
20815947020073Cure Catheter®M12C2016-09-24
20815947020080Cure Catheter®M14C2016-09-24
20815947020097Cure Catheter®M16C2016-09-24
20815947020103Cure Catheter®M18C2016-09-24
20815947020110Cure Catheter®M12U2016-09-24
20815947020127Cure Catheter®M14U2016-09-24
20815947020134Cure Catheter®M16U2016-09-24
20815947020158Cure Pocket Coude™M12ULC2016-12-30
20815947020165Cure Pocket Coude™M14ULC2016-12-30
20815947020172Cure Pocket Coude™M16ULC2016-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610075096152VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096169VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096176VaProHOLLISTER INCORPORATEDEZD2026-06-06
10197344162031MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-20
10197344162178MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-14
10197344162024MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162048MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162055MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162062MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162079MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162116MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162123MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162130MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162147MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162154MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162161MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162185MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162192MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162208MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162215MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162222MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162239MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162246MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162253MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162260MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162277MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10704411008828AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008835AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008842AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02