T-SPeC 107

GUDID 00856995003003

Transurethral Suprapubic endo-Cystostomy

SWAN VALLEY MEDICAL, INCORPORATED

Suprapubic drainage catheter

• Primary Device ID: 00856995003003
• NIH Device Record Key: 6252f336-944a-469f-b8aa-3535d500e4c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-SPeC
• Version Model Number: T7
• Catalog Number: 107
• Company DUNS: 795608012
• Company Name: SWAN VALLEY MEDICAL, INCORPORATED
• 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: 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

Customer Support Contacts

• Phone: 406-837-1500
• Email: cs@swanvalleymedical.com

Device Dimensions

• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856995003003 [Primary]
GS1	08569950031073 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120127

FDA Product Code

• FEX: Instrument, Catheter, Punch

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: 2020-04-01
• Device Publish Date: 2020-03-10

On-Brand Devices [T-SPeC]

• 00856995003010: Transurethral Suprapubic endo-Cystostomy
• 00856995003003: Transurethral Suprapubic endo-Cystostomy
• 08569950031141: Transurethral Suprapubic endo-Cystostomy
• 08569950031073: Transurethral Suprapubic endo-Cystostomy