IVOS - A self-contained computerized optical analyzer - HAMILTON THORNE, INC.

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.

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More Product Details

Catalog Number

-

Brand Name

IVOS

Version/Model Number

IVOS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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 Details

Product Code

GKL

Product Code Name

Counter, Cell, Automated (Particle Counter)

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAMILTON THORNE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53