TVUS/HSG-Cath MIS-50P

GUDID H671MIS50P1

Saline/Contrast Media Infusion Catheter, 5 Fr. with Peel-Away Introducer

UTAH MEDICAL PRODUCTS, INC.

Intrauterine imaging medium catheter

• Primary Device ID: H671MIS50P1
• NIH Device Record Key: 344fc012-90e2-43b5-8cc6-39391a2d38d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TVUS/HSG-Cath
• Version Model Number: Peel-Away Introducer
• Catalog Number: MIS-50P
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 30 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671MIS50P0 [Primary]
HIBCC	H671MIS50P1 [Package]; Contains: H671MIS50P0; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063611

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

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 [TVUS/HSG-Cath]

• H671MIS50ST1: Saline/Contrast Media Infusion Catheter, 5 Fr. with Integrated Stylet
• H671MIS50P1: Saline/Contrast Media Infusion Catheter, 5 Fr. with Peel-Away Introducer