EmbryoScope time-lapse incubator - The EmbryoScope time-lapse incubator (Version D) - Vitrolife A/S

Duns Number:308547608

Device Description: The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled t The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.

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More Product Details

Catalog Number

ESD20000

Brand Name

EmbryoScope time-lapse incubator

Version/Model Number

ESD20000

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

-

Product Code Details

Product Code

MQG

Product Code Name

Accessory, Assisted Reproduction

Device Record Status

Public Device Record Key

c55e751c-e75e-4951-85c7-51e54c04bebc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 26, 2016

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