Sonocath

GUDID B29606107X10

single unit

TITUS MEDICAL LLC

Uterine injector

• Primary Device ID: B29606107X10
• NIH Device Record Key: 680fb006-70e5-4da1-9e6b-2cbc3f59634d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonocath
• Version Model Number: 06-107X1
• 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
GS1	00850011427040 [Secondary]
HIBCC	B29606107X10 [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: 2017-01-20

On-Brand Devices [Sonocath]

• B29606107X400: Case of 40 Units
• B29606107X10: single unit
• B29606107X0: box of 10 units
• B29606105X400: Case of 40 Units
• B29606105X10: single unit
• B29606105X0: box of 10 units
• B2906105X30: Case of 300 Units