LETZ DLS-100

GUDID H671DLS1001

Electrode Sampler #1, Disposable Electrosurgical Loop and Ball Electrodes, Includes 1 ea. DLP-S11, 2 ea. DLP-M11, 1 ea. DLP-W11, 1 ea. DBL-311, & 1 ea. DBL-511

UTAH MEDICAL PRODUCTS, INC.

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: H671DLS1001
• NIH Device Record Key: 7557c1a3-e2a7-4cfe-8b60-4ee5dce2f3cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LETZ
• Version Model Number: Electrode Sampler #1
• Catalog Number: DLS-100
• 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	H671DLS1000 [Primary]
HIBCC	H671DLS1001 [Package]; Contains: H671DLS1000; 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 [LETZ]

• H671DLS3001: Electrode Sampler #3, Disposable Electrosurgical Loop and Ball Electrodes, Includes 1 ea. DLP-T1
• H671DLS2001: Electrode Sampler #2, Disposable Electrosurgical Loop and Ball Electrodes, Includes 2 ea. DLP-S1
• H671DLS1001: Electrode Sampler #1, Disposable Electrosurgical Loop and Ball Electrodes, Includes 1 ea. DLP-S1
• H671DLPT112: Electrosurgical Loop Electrode, 5mm Wide X 5mm Deep, Round Loop, 11cm Shaft Length