Handling Pipette

GUDID 10805360014189

VITROLIFE INC.

User-induced micropipette

• Primary Device ID: 10805360014189
• NIH Device Record Key: bfb2a8bd-4a5a-4768-a6d3-678ff71df11f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handling Pipette
• Version Model Number: 15537
• Company DUNS: 051915038
• Company Name: VITROLIFE INC.
• Device Count: 10
• 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: true
• 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	00805360014182 [Primary]
GS1	10805360014189 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991104

FDA Product Code

• MQH: Microtools, Assisted Reproduction (Pipettes)

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: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [Handling Pipette]

• 10805360014196: 15538
• 10805360014189: 15537
• 10805360014172: 15536
• 10805360014165: 15535
• 10805360014158: 15534
• 10805360014141: 15533
• 10805360014127: 15532
• 10805360014110: 15531
• 10805360014103: 15530