EmbryoScope+ - EmbryoScope+ consists of the following devices - Vitrolife A/S

Duns Number:308547608

Device Description: EmbryoScope+ consists of the following devices with the following indications for use:The EmbryoScope+ consists of the following devices with the following indications for use:The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by theEmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotatedinformation on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not controlany hardware components in the EmbryoScope+ incubator.The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

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More Product Details

Catalog Number

16401

Brand Name

EmbryoScope+

Version/Model Number

ES-P1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173264

Product Code Details

Product Code

MQG

Product Code Name

Accessory, Assisted Reproduction

Device Record Status

Public Device Record Key

f0bd1999-a8f2-4f62-a7ea-792f8d5f23ac

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITROLIFE A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 2