Hatching Pipette

GUDID 10805360016169

VITROLIFE INC.

User-induced micropipette

• Primary Device ID: 10805360016169
• NIH Device Record Key: 6401d785-ba7f-438f-bdae-dca81f45fc12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hatching Pipette
• Version Model Number: 15109
• 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: 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	00805360016162 [Unit of Use]
GS1	10805360016169 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-21
• Device Publish Date: 2016-09-23

On-Brand Devices [Hatching Pipette]

• 10805360018897: 15140
• 10805360018873: 15139
• 10805360018736: 15670
• 10805360017159: 15141
• 10805360016190: 15111
• 10805360016183: 15110
• 10805360016169: 15109
• 10805360016138: 15108
• 10805360016121: 15107
• 10805360016114: 15106
• 10805360016107: 15105
• 10805360016091: 15104
• 10805360016077: 15103
• 10805360016060: 15102
• 10805360016053: 15130