Holding Pipette

GUDID 17350025912087

Vitrolife Sweden AB

User-induced micropipette User-induced micropipette User-induced micropipette User-induced micropipette User-induced micropipette

• Primary Device ID: 17350025912087
• NIH Device Record Key: 4b4c35ce-4a22-49c1-8178-b59615550992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holding Pipette
• Version Model Number: 14340
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 20
• 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	07350025912080 [Unit of Use]
GS1	17350025912087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991700

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 [Holding Pipette]

• 17350025914135: 14393
• 17350025912087: 14340
• 17350025912018: 14333
• 17350025911912: 14323
• 17350025911868: 14318
• 17350025911844: 14316
• 17350025911769: 14308