Ultrasound Transducer Cover

GUDID 17350025911615

Vitrolife Sweden AB

Body-orifice ultrasound imaging transducer cover, basic

• Primary Device ID: 17350025911615
• NIH Device Record Key: 05868508-1537-4535-bf67-814909f0aac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound Transducer Cover
• Version Model Number: 14221
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350025911618 [Primary]
GS1	17350025911615 [Package]; Contains: 07350025911618; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241662

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2025-04-24
• Device Publish Date: 2025-04-16

On-Brand Devices [Ultrasound Transducer Cover]

• 17350025911639: 14219
• 17350025911622: 14220
• 17350025911615: 14221