FlexTrode® Malleable Electrode

GUDID 00846338001063

ELLIQUENCE, LLC

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00846338001063
• NIH Device Record Key: 580587e2-3f25-4b7a-aabb-b019bcc8a262
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexTrode® Malleable Electrode
• Version Model Number: FT-L3/S
• 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	00846338001063 [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 [FlexTrode® Malleable Electrode]

• 00846338001124: FT-W/S
• 00846338001117: FT-S/S
• 00846338001094: FT-N/S
• 00846338001087: FT-L7/S
• 00846338001070: FT-L5/S
• 00846338001063: FT-L3/S
• 00846338001056: FT-D/S
• 00846338001049: FT-B3/S
• 00846338001032: FT-B2/S
• 00846338001025: FT-B1/S