UriSponge™ 8U033S50

GUDID 58053326011714

UriSponge™ - Urine Collection, Transport, and Preservation System 100mm lenght x 16mm diameter

COPAN ITALIA SPA

Non-evacuated urine specimen container IVD, preservative

• Primary Device ID: 58053326011714
• NIH Device Record Key: b9530b4a-33a3-4794-9791-5d33dfe7dab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UriSponge™
• Version Model Number: 8U033S50
• Catalog Number: 8U033S50
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 50
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08053326011719 [Unit of Use]
GS1	38053326011710 [Primary]
GS1	58053326011714 [Package]; Contains: 38053326011710; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232565

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2025-03-20
• Device Publish Date: 2025-03-12

Devices Manufactured by COPAN ITALIA SPA

• 58053326011714 - UriSponge™: 2025-03-20UriSponge™ - Urine Collection, Transport, and Preservation System 100mm lenght x 16mm diameter
• 58053326011714 - UriSponge™: 2025-03-20 UriSponge™ - Urine Collection, Transport, and Preservation System 100mm lenght x 16mm diameter
• 58053326011684 - FLOQSwabs®: 2024-12-26 Specimen collection swab, regular, breaking point 80 mm, in tube
• 58053326011592 - UTM®: 2024-11-21 Copan Universal Transport Medium (UTM-RT®) System 3 mL
• 58053326011608 - UTM®: 2024-11-21 Copan Universal Transport Medium (UTM-RT®) System 3 mL + One regular flocked swab
• 58053326011615 - UTM®: 2024-11-21 Copan Universal Transport Medium (UTM-RT®) System 3 mL + One minitip flocked swab
• 58053326011509 - FLOQSwabs®: 2024-07-10 Specimen collection swab, regular, breaking point 60mm, in tube
• 58053326011523 - FLOQSwabs®: 2024-07-10 Specimen collection swab, regular, 60 mm breakpoint, in tube
• 28053326004524 - Sample Diluent Tube: 2024-05-15 1ML SAMPLE DILUENT TUBE IN BULK