FDA.reportPublic FDA data

SUPRA-FOLEY

Primary DI
H671SFS161000
Brand
SUPRA-FOLEY
Company
UTAH MEDICAL PRODUCTS, INC.
Model
16Fr Catheterization Kit
Catalog number
SF-S16-100
Device description
Suprapubic Catheter Introducer Kit, 16 French
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K884061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884061000ADD-A-CATHFemcare , Ltd.1988-10-25KOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671SFS161001PackageHIBCC5In Commercial Distribution
H671SFS161000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic catheterization kitA collection of devices intended for the percutaneous introduction of an included catheter into the bladder through a suprapubic (above the pubic arch) incision, for the drainage of urine. In addition to the suprapubic catheter, it includes an introducer (typically a cannula/sheath with trocar), and one or more non-dedicated procedural supportive devices (e.g., scalpel, dressing, gauze, drape, disinfectant); it does not include a pharmaceutical. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Contacts#

Phone, Email table
PhoneEmail
800-533-4984customer@utahmed.com

Regulatory Flags#

DUNS number
094651270
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H671303TT0CMITender Touch Cup303TT2016-09-23
H671303TTL0CMITender Touch Cup303TTL2016-09-23
H671404TT0CMITender Touch Cup404TT2016-09-23
H67141828050UMBILI-CATHSingle-Lumen Polyurethane41828052016-09-23
H67141835050UMBILI-CATHSingle-Lumen Polyurethane41835052016-09-23
H67141850050UMBILI-CATHSingle-Lumen Polyurethane41850052016-09-23
H67141865050UMBILI-CATHSingle-Lumen Polyurethane41865052016-09-23
H67142828050UMBILI-CATHDual-Lumen Polyurethane42828052016-09-23
H67142835050UMBILI-CATHDual-Lumen Polyurethane42835052016-09-23
H67142850050UMBILI-CATHDual-Lumen Polyurethane42850052016-09-23
H67143850050UMBILI-CATHTriple-Lumen Polyurethane43850052016-09-23
H671444FC0CMIFlex Cup444FC2016-09-23
H671505TT0CMIUltra Cup505TT2016-09-23
H671505TTL0CMIUltra Cup505TTL2016-09-23
H671506TTL0CMIUltra Cup506TTL2016-09-23
H671600TT0CMISecure Cup600TT2016-09-23
H671606TT0CMISecure Cup606TT2016-09-23
H671IUP4000INTRANPlusIUP-4002016-09-23
H671IUP4500INTRANPlusIUP-4502016-09-23
H671IUP5000INTRANPlusIUP-5002016-09-23

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