FDA.reportPublic FDA data

Cure Ultra Male Catheter

Primary DI
20815947021063
Brand
Cure Ultra Male Catheter
Company
CURE MEDICAL LLC
Model
ULTRA M14
Device description
Sterile Intermittent Catheter, Straight Tip
Published
2017-04-07
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
KODCatheter, Urological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080881000CURE CATHETER CLOSED SYSTEMCure Medical, LLC2008-06-11KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815947021066PackageGS130In Commercial Distribution
20815947021063PackageGS110In Commercial Distribution
00815947021069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081594702106610815947021066
2081594702106320815947021063
00815947021069008159470210698159470210690815947021069

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
Length16Inch
Length41Centimeter

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
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
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10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
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10192253029086DoverCardinal Health 200, LLCKOD2025-04-07
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10192253029116DoverCardinal Health 200, LLCKOD2025-04-07
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10192253030310DoverCardinal Health 200, LLCKOD2025-04-07
10192253030327DoverCardinal Health 200, LLCKOD2025-04-07
10192253030334DoverCardinal Health 200, LLCKOD2025-04-07
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10192253030624DoverCardinal Health 200, LLCKOD2025-01-14
10192253031409DoverCardinal Health 200, LLCKOD2025-01-14
10192253031416DoverCardinal Health 200, LLCKOD2025-01-14
10192253038897DoverCardinal Health 200, LLCKOD2025-01-14
10192253066203DoverCardinal Health 200, LLCKOD2024-09-04
10192253066210DoverCardinal Health 200, LLCKOD2024-09-04
10192253066227DoverCardinal Health 200, LLCKOD2024-09-04
10192253066234DoverCardinal Health 200, LLCKOD2024-09-04
10192253066241DoverCardinal Health 200, LLCKOD2024-09-04
10192253066258DoverCardinal Health 200, LLCKOD2024-09-04
10192253066265DoverCardinal Health 200, LLCKOD2024-09-04