Disc-FX® Guidewire

GUDID 00846338001322

ELLIQUENCE, LLC

Gastro-urological guidewire, single-use

• Primary Device ID: 00846338001322
• NIH Device Record Key: 717e9000-bb9a-4078-b426-cf69ce0af58f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disc-FX® Guidewire
• Version Model Number: DFX-GW-S/1
• 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	00846338001322 [Package]; Contains: 00846338010911; Package: Box (DFX-GW-S) [10 Units]; In Commercial Distribution
GS1	00846338010911 [Primary]

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-10-05
• Device Publish Date: 2018-07-26

On-Brand Devices [Disc-FX® Guidewire]

• 00846338001322: DFX-GW-S/1
• 10846338001480: DFX-GW-20/1
• 10846338001473: DFX-GW-18/1