Titus Medical HSG Catheter 5fr

GUDID 00850011427071

HSG Catheter 5fr single unit

TITUS MEDICAL LLC

Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector

• Primary Device ID: 00850011427071
• NIH Device Record Key: 0fa81c88-43c3-4584-ba1e-8aac92b62828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titus Medical HSG Catheter 5fr
• Version Model Number: 06-105F
• Company DUNS: 080306309
• Company Name: TITUS MEDICAL 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com
• Phone: 888-550-6185
• Email: info@titusmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011427071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092969

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

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: 2020-10-22
• Device Publish Date: 2020-10-14

On-Brand Devices [Titus Medical HSG Catheter 5fr ]

• 00850011427095: Case of 40 units HSG Catheter 5fr
• 00850011427088: HSG CATHETER 5FR BOX OF 10
• 00850011427071: HSG Catheter 5fr single unit