Follicle Aspiration Set, Double Lumen

GUDID 17350025911578

Vitrolife Sweden AB

IVF oocyte aspiration needle, single-use

• Primary Device ID: 17350025911578
• NIH Device Record Key: 8371eac3-e22b-409c-b6bd-59046cb20b59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Follicle Aspiration Set, Double Lumen
• Version Model Number: 14158
• 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	07350025911571 [Primary]
GS1	17350025911578 [Package]; Contains: 07350025911571; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991273

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: 2016-09-09

On-Brand Devices [Follicle Aspiration Set, Double Lumen]

• 17350025914111: 14168
• 17350025911608: 14161
• 17350025911578: 14158
• 17350025911509: 14151
• 17350025911493: 14150
• 17350025911479: 14148
• 17350025911301: 14131
• 17350025911288: 14129
• 17350025911134: 14114
• 17350025911103: 14111
• 17350025911080: 14109
• 17350025911073: 14108
• 17350025911042: 14105
• 07350025911014: 14102