HYASE-10X

GUDID 07350025910833

Vitrolife Sweden AB

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium

• Primary Device ID: 07350025910833
• NIH Device Record Key: d88e5929-57b3-4729-9513-996b1a7d28d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYASE-10X
• Version Model Number: 10183
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 4
• 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	07350025910833 [Unit of Use]
GS1	17350025910830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000627

FDA Product Code

• MQL: Media, Reproductive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-01
• Device Publish Date: 2021-06-23

On-Brand Devices [HYASE-10X]

• 17350025910267: 10017
• 07350025910833: 10183
• 07350025910765: 10176