Cyst Puncture Needle without Stylet

GUDID 17350025912315

Vitrolife Sweden AB

Endoscopic cyst-aspiration set

• Primary Device ID: 17350025912315
• NIH Device Record Key: c025f4f0-590e-4d51-a0b7-0ac1aa3e1c2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyst Puncture Needle without Stylet
• Version Model Number: 14804
• 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	07350025912318 [Primary]
GS1	17350025912315 [Package]; Contains: 07350025912318; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862365

FDA Product Code

• KNA: Instrument, Manual, Specialized Obstetric-Gynecologic

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: 2016-09-14

On-Brand Devices [Cyst Puncture Needle without Stylet]

• 07350025915616: 17810
• 07350025915593: 17807
• 17350025915569: 17804
• 17350025912414: 14814
• 07350025912370: 14810
• 17350025912346: 14807
• 17350025912315: 14804