Pathfinder Plus PA701

GUDID H671PA7011

Continuous and Plsatile Irrigation Bulb

UTAH MEDICAL PRODUCTS, INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: H671PA7011
• NIH Device Record Key: c2b001a9-2640-4efb-b7db-efa07b60b595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathfinder Plus
• Version Model Number: Ureteroscopy Irrigation Bulb
• Catalog Number: PA701
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	H671PA7010 [Primary]
HIBCC	H671PA7011 [Package]; Contains: H671PA7010; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001874

FDA Product Code

• LJS: Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-23

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