Depth-Gauge FlexTrode®

GUDID 00846338001001

ELLIQUENCE, LLC

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00846338001001
• NIH Device Record Key: 795aaf1d-ccf3-47f9-af40-b62b0efd6143
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Depth-Gauge FlexTrode®
• Version Model Number: FT-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	00846338001001 [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 [Depth-Gauge FlexTrode®]

• 00846338008147: FT-W
• 00846338008130: FT-N
• 00846338008123: FT-L7
• 00846338008116: FT-L5
• 00846338008109: FT-L3
• 00846338008093: FT-B3
• 00846338008086: FT-B2
• 00846338008079: FT-B1
• 00846338001100: FT-D
• 00846338001001: FT-S