LIBERTY PFS-043

GUDID H671PFS0430

Pelvic Floor Execiser System, Rectal Exerciser, For use with Liberty Stimulator PFS-200 only

UTAH MEDICAL PRODUCTS, INC.

Perineal orifice incontinence-control electrical stimulation system, remote control

• Primary Device ID: H671PFS0430
• NIH Device Record Key: 87bc09ab-31d6-45a6-8b47-7d547b33c951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIBERTY
• Version Model Number: Rectal Exerciser Probe
• Catalog Number: PFS-043
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	H671PFS0430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960496

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [LIBERTY]

• H671PFS2000: Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Includ
• H671PFS0430: Pelvic Floor Execiser System, Rectal Exerciser, For use with Liberty Stimulator PFS-200 only
• H671PFS0420: Pelvic Floor Execiser System, Extended Vaginal Exerciser, For use with Liberty Stimulator PFS-20
• H671PFS0410: Pelvic Floor Execiser System, Vaginal Exerciser, For use with Liberty Stimulator PFS-200 only