UtahBall DBL-511

GUDID H671DBL5112

Electrosurgical Electrode, 5mm Ball, 11cm Shaft

UTAH MEDICAL PRODUCTS, INC.

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: H671DBL5112
• NIH Device Record Key: 1ec37ede-c6d9-488d-beec-c5971548e565
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UtahBall
• Version Model Number: Ball Electrode
• Catalog Number: DBL-511
• 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

• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671DBL5110 [Primary]
HIBCC	H671DBL5111 [Package]; Contains: H671DBL5110; Package: Box [10 Units]; In Commercial Distribution
HIBCC	H671DBL5112 [Package]; Contains: H671DBL5111; Package: Overpack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905263

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & 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: 5
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [UtahBall]

• H671DBL5112: Electrosurgical Electrode, 5mm Ball, 11cm Shaft
• H671DBL5051: Electrosurgical Electrode, 5mm Ball, 5.5cm Shaft
• H671DBL3112: Electrosurgical Electrode, 3mm Ball, 11cm Shaft