SQA-Vision Sperm Quality Analyzer VS-MA-00892-00

GUDID 07290012140792

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Spermatozoa/semen analyser IVD, automated
Primary Device ID07290012140792
NIH Device Record Key3ba2142d-dd48-4f37-9286-f4cb3298978a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSQA-Vision Sperm Quality Analyzer
Version Model NumberVS-MA-00892-00
Catalog NumberVS-MA-00892-00
Company DUNS514680529
Company NameM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290012140792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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