SUPRA-FOLEY SF-S16-100

GUDID H671SFS161001

Suprapubic Catheter Introducer Kit, 16 French

UTAH MEDICAL PRODUCTS, INC.

Suprapubic catheter introducer

• Primary Device ID: H671SFS161001
• NIH Device Record Key: 69abe716-8809-4aa3-b71d-b93fc52e6727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPRA-FOLEY
• Version Model Number: 16Fr Catheterization Kit
• Catalog Number: SF-S16-100
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com

Device Dimensions

• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671SFS161000 [Primary]
HIBCC	H671SFS161001 [Package]; Contains: H671SFS161000; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884061

FDA Product Code

• KOB: Catheter, Suprapubic (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [SUPRA-FOLEY]

• H671SFS181011: Suprapubic Catheter Introducer Kit, 18 French
• H671SFS168511: Suprapubic Catheter Introducer, 16 French
• H671SFS161001: Suprapubic Catheter Introducer Kit, 16 French
• H671SFS141041: Suprapubic Catheter Introducer Kit, 14 French
• H671SFS128521: Suprapubic Catheter Introducer, 12 French