Transducer Cover

GUDID 17350025911646

Vitrolife Sweden AB

Body-orifice ultrasound imaging transducer cover, basic, sterile

• Primary Device ID: 17350025911646
• NIH Device Record Key: 506f505f-6509-4f11-8543-5775ea1aa15d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer Cover
• Version Model Number: 14201
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 25
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350025911649 [Unit of Use]
GS1	17350025911646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862364

FDA Product Code

• HEM: Imager, Ultrasonic Obstetric-Gynecologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-13

On-Brand Devices [Transducer Cover]

• 17350025911677: 14204
• 17350025911653: 14202
• 17350025911646: 14201