Ikaros

GUDID 04250406400003

MetaSystems Hard & Software GmbH

Karyotyping cell-image analyser Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD Karyotyping cell-image analyser IVD

• Primary Device ID: 04250406400003
• NIH Device Record Key: 0274cfb4-0dc7-4825-a4ff-047a2ed14a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ikaros
• Version Model Number: Karyotyping System
• Company DUNS: 329631642
• Company Name: MetaSystems Hard & Software GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250406400003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940240

FDA Product Code

• LNJ: Analyzer, Chromosome, Automated

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

Devices Manufactured by MetaSystems Hard & Software GmbH

• 04250406401000 - Neon: 2023-07-18
• 04250406460007 - Metafer: 2023-06-19
• 04250406400003 - Ikaros: 2018-07-06
• 04250406400003 - Ikaros: 2018-07-06