Cyst Puncture Needle with Stylet

GUDID 07350025912301

Vitrolife Sweden AB

Endoscopic cyst-aspiration set

• Primary Device ID: 07350025912301
• NIH Device Record Key: 0d3fe7af-bdc3-4189-aea8-bbe660902065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyst Puncture Needle with Stylet
• Version Model Number: 14803
• 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	07350025912301 [Primary]
GS1	17350025912308 [Package]; Package: [10 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 with Stylet]

• 17350025915637: 17812
• 17350025915620: 17811
• 17350025915606: 17809
• 17350025915583: 17806
• 17350025915576: 17805
• 17350025915552: 17803
• 17350025912391: 14812
• 17350025912384: 14811
• 17350025912360: 14809
• 07350025912332: 14806
• 07350025912325: 14805
• 07350025912301: 14803