Trigger-Flex® Dart Bipolar System

GUDID 00846338001346

ELLIQUENCE, LLC

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00846338001346
• NIH Device Record Key: 7c2d2834-10a3-4bce-9730-56ed10995a2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trigger-Flex® Dart Bipolar System
• Version Model Number: DTFD-13
• 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	00846338001346 [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: 2019-04-23
• Device Publish Date: 2016-10-21

On-Brand Devices [Trigger-Flex® Dart Bipolar System]

• 00846338001407: DTFD-24
• 00846338001346: DTFD-13