OptiMicro DN-0400

GUDID H671DN04002

Disposable Electrosurgical Electrode, 4cm Long Straight Tip

UTAH MEDICAL PRODUCTS, INC.

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: H671DN04002
• NIH Device Record Key: 9af7161c-5858-429e-b872-873fd6a07a44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMicro
• Version Model Number: Needle Electrode, 4cm
• Catalog Number: DN-0400
• 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

• Length: 4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671DN04000 [Primary]
HIBCC	H671DN04001 [Package]; Contains: H671DN04000; Package: Box [10 Units]; In Commercial Distribution
HIBCC	H671DN04002 [Package]; Contains: H671DN04001; Package: Overpack [20 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 [OptiMicro]

• H671DN08102: Disposable Electrosurgical Electrode, 8cm Long Straight Tip with Retracted Insulation
• H671DN08002: Disposable Electrosurgical Electrode, 8cm Long Straight Tip
• H671DN04452: Disposable Electrosurgical Electrode, 4cm Long with 10mm Long 45 Degree Tip
• H671DN04002: Disposable Electrosurgical Electrode, 4cm Long Straight Tip
• H671DN03452: Disposable Electrosurgical Electrode, 3cm Long with 3mm Long 45 Degree Tip
• H671DN03002: Disposable Electrosurgical Electrode, 3cm Long Straight Tip
• H671DN02452: Disposable Electrosurgical Electrode, 2cm Long with 3mm Long 45 Degree Tip
• H671DN02002: Disposable Electrosurgical Electrode, 2cm Long Straight Tip