HSG Catheter

GUDID B296E0700FIRM00

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 Uterine injector Uterine injector Uterine injector

• Primary Device ID: B296E0700FIRM00
• NIH Device Record Key: 6d139d3a-276d-402e-b2c8-292ba1be2cda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HSG Catheter
• Version Model Number: E0700-FIRM
• 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	B296E0700FIRM00 [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 [HSG Catheter]

• B296E07070: single unit
• B296E0700FR03: single unit
• B296E0700FIRM00: single unit
• B296E050507: single unit
• B296E0500FR01: single unit
• B296E0500FIRM0: single unit
• B296C070709: Case of 40 Units
• B296C0700FR01: Case of 40 Units
• B296C0700FIRM0: Case of 40 Units
• B296C050505: Case of 40 Units
• B296C0500FR0: Case of 40 Units
• B296C0500FIRM0: Case of 40 Units
• B296B070708: box of 10 units
• B296B0700FR00: box of 10 units
• B296B0700FIRM0: box of 10 units
• B296B05050: box of 10 units
• B296B0500FR0: box of 10 units
• B296B0500FIRM0: box of 10 units
• B29606107F400: Case of 40 Units
• B29606107F10: single unit
• B29606107F0: box of 10 units
• B296061070: Case of 100 Units Bulk
• B29606105F400: Case of 40 Units
• B29606105F10: single unit
• B29606105F0: box of 10 units
• B296061050: Case of 100 Units Bulk