Empire® microIncision™

GUDID 00846338006297

ELLIQUENCE, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00846338006297
• NIH Device Record Key: c12b8784-79ab-4d1b-bf9d-bee32b07dd92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empire® microIncision™
• Version Model Number: TEE327
• Company DUNS: 019872358
• Company Name: ELLIQUENCE, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846338006297 [Primary]

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: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-22

On-Brand Devices [Empire® microIncision™]

• 00846338006303: TEE328
• 00846338006297: TEE327
• 00846338006280: TEE326
• 00846338006075: TEE305
• 00846338006037: TEE301