S-Cath™

GUDID 15055140702231

S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 12Fr. 10cc, 42cm

MEDIPLUS LTD

Suprapubic drainage catheter

• Primary Device ID: 15055140702231
• NIH Device Record Key: 58fda13f-d3b3-482f-bd4f-6279f9b158f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-Cath™
• Version Model Number: 5753
• Company DUNS: 228480810
• Company Name: MEDIPLUS LTD
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +4401494551200
• Email: help@mediplus.co.uk

Device Dimensions

• Length: 42 Centimeter
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055140702234 [Primary]
GS1	15055140702231 [Package]; Contains: 05055140702234; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132890

FDA Product Code

• KOB: CATHETER, SUPRAPUBIC (AND 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: 2018-07-06
• Device Publish Date: 2015-10-17

On-Brand Devices [S-Cath™]

• 15055140702262: S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 14Fr. 10cc, 42cm
• 15055140702231: S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 12Fr.
• 15055140701333: S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 12Fr. 10cc, 42cm
• 15055140701203: S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 16Fr. 1
• 15055140701197: S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 14Fr.
• 15055140700091: S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 16Fr. 10cc, 42cm