Blastomere Biosy Pipette

GUDID 17350025912117

Vitrolife Sweden AB

User-induced micropipette

• Primary Device ID: 17350025912117
• NIH Device Record Key: 9012a96e-ad68-4081-8b4c-79ed7cca2db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blastomere Biosy Pipette
• Version Model Number: 14343
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 5
• 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	07350025912110 [Unit of Use]
GS1	17350025912117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022643

FDA Product Code

• MQH: Microtools, Assisted Reproduction (Pipettes)

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 [Blastomere Biosy Pipette]

• 17350025912117: 14343
• 17350025912049: 14336
• 17350025911998: 14331