Follicle Aspiration Set Single Lumen, Luer

GUDID 17350025915361

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use

• Primary Device ID: 17350025915361
• NIH Device Record Key: 934745dd-a5c1-4882-b386-d4352ba916a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration Set Single Lumen, Luer
• Version Model Number: 17154
• 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	07350025915364 [Primary]
GS1	17350025915361 [Package]; Contains: 07350025915364; 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: 2017-09-26

On-Brand Devices [ Follicle Aspiration Set Single Lumen, Luer]

• 17350025915361: 17154
• 17350025915354: 17152
• 17350025915316: 17147
• 17350025915293: 17140
• 17350025915286: 17137