Follicle Aspiration Set, Reduced Single Lumen

GUDID 17350025914296

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use

• Primary Device ID: 17350025914296
• NIH Device Record Key: e3e2ab23-03eb-48de-ba59-8e532227ab46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration Set, Reduced Single Lumen
• Version Model Number: 14178
• 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	07350025914299 [Primary]
GS1	17350025914296 [Package]; Contains: 07350025914299; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082727

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: 2016-09-23

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

• 17350025914753: 14180
• 17350025914746: 14179
• 17350025914296: 14178
• 07350025914282: 14177
• 17350025914272: 14176
• 17350025914234: 14175