FDA.reportPublic FDA data

S-Cath™

Primary DI
05055140704061
Brand
S-Cath™
Company
MEDIPLUS LTD
Model
5759-L
Device description
Silicone Suprapubic Foley (open tip) Catheter, with Introducer Set, 16Fr. 10cc, 42cm, Long
Published
2025-10-10
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
KOBCatheter, Suprapubic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOBCatheter, Suprapubic (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132890000SUPRAPUBIC CATHETER AND INTRODUCER SETMediplus , Ltd.2014-01-17KOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15055140704068PackageGS15In Commercial Distribution
05055140704061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505514070406815055140704068
05055140704061050551407040615055140704061

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic drainage catheterA flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length42Centimeter

Regulatory Flags#

DUNS number
228480810
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
05055140702807MediplusA202Ac2025-08-29
15055140702804MediplusA202Ac2025-08-29
05055140700490Mediplus22702016-09-16
05055140700513Mediplus22722016-09-16
05055140700537Mediplus22742016-09-16
05055140700681Mediplus51042016-09-16
05055140700759Mediplus23152016-09-16
05055140700773Mediplus23202016-09-16
05055140701107Mediplus2300E2016-09-16
05055140701114Mediplus2244-1E2016-09-16
05055140701121Mediplus51052016-09-16
05055140701138Mediplus59012016-09-16
05055140701237Mediplus58322016-09-16
05055140701855Mediplus53332016-09-16
05055140701954Mediplus54502016-09-16
05055140702005Mediplus56102016-09-16
05055140702012Mediplus56202016-09-16
05055140702272Mediplus5801/12016-09-16
05055140702296Mediplus58062016-09-16
05055140702319Mediplus58122016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842071150952AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071150976AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152758MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152765MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152772MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
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00842071149949MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149956MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149963MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149970MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149987MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149994MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071150006MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16