DEVICE: Ikaros (04250406400003)

Device Identifier (DI) Information

Ikaros
Karyotyping System
In Commercial Distribution

MetaSystems Hard & Software GmbH
04250406400003
GS1

1
329631642 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33936 Karyotyping cell-image analyser IVD
An automated laboratory instrument designed for analysis of cell images, either directly from cell preparations (e.g., smears) or from cell images obtained from other devices (e.g., microscopes), that can identify and classify abnormalities in the chromosome (e.g., translocations). It usually provides results as a graphic (karyotype) normally applied for the pre and postnatal diagnosis of birth defects, chromosomal abnormalities, genetic disorders (e.g., Down syndrome), cancer, and cancer treatment follow up. The device typically includes display, recording, and communication capabilities.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LNJ Analyzer, Chromosome, Automated
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K940240 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0274cfb4-0dc7-4825-a4ff-047a2ed14a18
March 10, 2021
4
September 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No
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Customer Contact

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No Customer Contact currently defined
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