EmbryoGlue

GUDID 07350025910048

Vitrolife Sweden AB

IVF medium

• Primary Device ID: 07350025910048
• NIH Device Record Key: 45ec3ba0-8e6c-456e-a3ec-e1ecc3e8a02d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmbryoGlue
• Version Model Number: 10085
• 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	07350025910048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031015

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-24
• Device Publish Date: 2016-09-13

On-Brand Devices [EmbryoGlue]

• 07350025910048: 10085
• 07350025910901: 10190