UtahLoop DLP-M11

GUDID H671DLPM112

Electrosurgical Loop Electrode, 15mm Wide X 12mm Deep, Round Loop, 11cm Shaft Length, with Safe-T-Gauge

UTAH MEDICAL PRODUCTS, INC.

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: H671DLPM112
• NIH Device Record Key: ec051dbc-d4a4-4615-8dc3-eadf6daa0563
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UtahLoop
• Version Model Number: LETZ Electrode
• Catalog Number: DLP-M11
• 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

• Width: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671DLPM110 [Primary]
HIBCC	H671DLPM111 [Package]; Contains: H671DLPM110; Package: Box [10 Units]; In Commercial Distribution
HIBCC	H671DLPM112 [Package]; Contains: H671DLPM111; 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 [UtahLoop]

• H671DLPW112: Electrosurgical Loop Electrode, 20mm Wide X 12mm Deep, Round Loop, 11cm Shaft Length, with Safe-
• H671DLPSQ12: Electrosurgical Loop Electrode, 10mm Wide X 10mm Deep, Square Loop, 11cm Shaft Length, with Safe
• H671DLPS112: Electrosurgical Loop Electrode, 10mm Wide X 10mm Deep, Round Loop, 11cm Shaft Length, with Safe-
• H671DLPM112: Electrosurgical Loop Electrode, 15mm Wide X 12mm Deep, Round Loop, 11cm Shaft Length, with Safe-
• H671DLPL112: Electrosurgical Loop Electrode, 20mm Wide X 15mm Deep, Round Loop, 11cm Shaft Length, with Safe-
• H671DLPE112: Electrosurgical Loop Electrode, 25mm Wide X 22mm Deep, Round Loop, 11cm Shaft Length, with Safe-
• H671DLPB112: Electrosurgical Loop Electrode, 25mm Wide X 8mm Deep, Round Loop, 11cm Shaft Length, with Safe-T