Urethral Catheter Electrode

GUDID 18054655025979

SPES MEDICA SRL

Urodynamic measurement system

• Primary Device ID: 18054655025979
• NIH Device Record Key: f0401bc2-f808-441c-884f-fd785cb7abb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urethral Catheter Electrode
• Version Model Number: UE002
• Company DUNS: 514029771
• Company Name: SPES MEDICA SRL
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054655025979 [Primary]

FDA Product Code

• FAP: Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-01
• Device Publish Date: 2021-05-24

On-Brand Devices [Urethral Catheter Electrode]

• 18054655026013: UE006
• 18054655025979: UE002