Surgeon's Preference

GUDID 20841019110045

Bipolar Pencil 18 Gauge Straight

Surgeons Preference, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 20841019110045
• NIH Device Record Key: 82b415fe-bbc3-4fb1-93f0-7f2d6ad33c59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgeon's Preference
• Version Model Number: T-500
• Company DUNS: 078872107
• Company Name: Surgeons Preference, LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-834-9500
• Email: kprario@ksp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019110041 [Primary]
GS1	10841019110048 [Package]; Contains: 00841019110041; Package: [10 Units]; In Commercial Distribution
GS1	20841019110045 [Package]; Contains: 00841019110041; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864402

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[20841019110045]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-04