Follicle Aspiration Set Reduced Single Lumen

GUDID 17350025915460

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use

• Primary Device ID: 17350025915460
• NIH Device Record Key: 53d28f43-cdd1-4c70-a80e-a9d7785cb52d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration Set Reduced Single Lumen
• Version Model Number: 17178
• 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	07350025915463 [Primary]
GS1	17350025915460 [Package]; Contains: 07350025915463; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-05

On-Brand Devices [Follicle Aspiration Set Reduced Single Lumen]

• 17350025915460: 17178
• 17350025915453: 17177
• 17350025915446: 17176
• 17350025915439: 17175