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.
07290012140792
GS1

1
514680529 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Spermatozoa/semen analyser IVD, automated A mains electricity (AC-powered) 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. The device operates with minimal technician involvement and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
GKZ Counter, Differential Cell
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K012352 000
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Sterilization

No
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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

3ba2142d-dd48-4f37-9286-f4cb3298978a
July 06, 2018
3
September 23, 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
No
Yes
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Customer Contact

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No Customer Contact currently defined
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