DEVICE: SQA-Vision Sperm Quality Analyzer (07290012140792)
Device Identifier (DI) Information
SQA-Vision Sperm Quality Analyzer
VS-MA-00892-00
In Commercial Distribution
VS-MA-00892-00
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
VS-MA-00892-00
In Commercial Distribution
VS-MA-00892-00
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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57855 | Spermatozoa/semen analyser IVD |
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GKZ | Counter, Differential Cell |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K012352 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3ba2142d-dd48-4f37-9286-f4cb3298978a
September 16, 2022
4
September 23, 2016
September 16, 2022
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined