ICSI

GUDID 17350025910274

Vitrolife Sweden AB

IVF medium

• Primary Device ID: 17350025910274
• NIH Device Record Key: 8c50db06-47c2-4729-86c3-7ae55b91d246
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICSI
• Version Model Number: 10111
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 5
• 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	07350025910277 [Unit of Use]
GS1	17350025910274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043116

FDA Product Code

• MQL: Media, Reproductive

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: 2020-01-24
• Device Publish Date: 2016-09-13

Devices Manufactured by Vitrolife Sweden AB

• 17350025911615 - Ultrasound Transducer Cover: 2025-04-24
• 17350025911622 - Ultrasound Transducer Cover: 2025-04-24
• 17350025911639 - Ultrasound Transducer Cover: 2025-04-24
• 17350025915477 - Follicle Aspiration Set Reduced Single Lumen, Luer: 2024-12-04
• 17350025915484 - Follicle Aspiration Set Reduced Single Lumen, Luer: 2024-12-04
• 07350025914251 - Ultra RapidWarm Blast: 2024-09-24
• 17350025915682 - Follicle Aspiration Set Reduced Single Lumen: 2024-07-10
• 17350025915699 - Follicle Aspiration Set Single Lumen: 2024-07-10