Follicle Aspiration Set, Reduced Double Lumen

GUDID 07350025915678

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use

• Primary Device ID: 07350025915678
• NIH Device Record Key: 2a140275-d15e-43cb-8002-ed8f9eb37b83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration Set, Reduced Double Lumen
• Version Model Number: 17187
• 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: 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	07350025915678 [Primary]
GS1	17350025915675 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172050

FDA Product Code

• MQE: Needle, Assisted Reproduction

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: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by Vitrolife Sweden AB

• 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
• 07350025910901 - EmbryoGlue: 2022-02-07
• 07350025910765 - HYASE-10X: 2022-01-10
• 07350025910833 - HYASE-10X: 2021-07-01