Duns Number:152161337
Device Description: A self-contained computerized optical analyzer used for evaluation of sperm samples. It wi A self-contained computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality.
Catalog Number
-
Brand Name
IVOS
Version/Model Number
IVOS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K920719
Product Code
GKL
Product Code Name
Counter, Cell, Automated (Particle Counter)
Public Device Record Key
9e1ebb66-302a-40af-a0b7-8134d22d9364
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
November 30, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 53 |