Follicle Aspiration Set Single Lumen, Luer with T

GUDID 17350025915200

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use

• Primary Device ID: 17350025915200
• NIH Device Record Key: e7ad88c1-fcb3-4fc1-84c4-5c47b8dfce58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration Set Single Lumen, Luer with T
• Version Model Number: 17123
• 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	07350025915203 [Primary]
GS1	17350025915200 [Package]; Contains: 07350025915203; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161970

FDA Product Code

• MQE: Needle, Assisted Reproduction

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: 2017-09-25

Devices Manufactured by Vitrolife Sweden AB

• 07350025910901 - EmbryoGlue: 2022-02-07
• 07350025910765 - HYASE-10X: 2022-01-10
• 07350025910833 - HYASE-10X: 2021-07-01
• 07350025910796 - G-RINSE: 2021-06-04
• 07350025910802 - ASP: 2021-06-04
• 07350025910819 - G-MOPS: 2021-06-04
• 07350025910826 - G-MOPS PLUS: 2021-06-04
• 07350025910604 - Gx-IVF: 2021-05-31