Ultra Catheter

GUDID B296C0620508

Case of 25 Units

TITUS MEDICAL LLC

Uterine injector

• Primary Device ID: B296C0620508
• NIH Device Record Key: 9c38b448-aaf3-4924-af8c-2bdbee4199fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Catheter
• Version Model Number: C06-205
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B296C0620508 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Ultra Catheter]

• B296E062050: single unit
• B296C0620508: Case of 25 Units
• B296062050: box of 10 units