SUPRA-FOLEY

Basic Information

• Brand Name: SUPRA-FOLEY
• Primary DI: H671SFS168510
• Version / Model: 16Fr Introducer
• Catalog Number: SF-S16-851
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2024-05-14
• Public Version Status: Update
• Public Device Record Key: a45deb1d-b88a-413d-8add-5ad5389a1c6a

Device Description

Suprapubic Catheter Introducer, 16 French

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	876.5090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67060	Suprapubic catheter introducer, single-use	A rigid, tubular, manual device(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It typically includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H671SFS168511	HIBCC	Box	10	In Commercial Distribution
Primary	H671SFS168510	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K884061	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	16	French