EmbryoSlide+ ic8 dish 16455

GUDID 05712714000041

The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer. The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release. The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.

Vitrolife A/S

Assisted reproduction procedure dish
Primary Device ID05712714000041
NIH Device Record Key0e435adb-466e-47f3-b384-d212900c2920
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbryoSlide+ ic8 dish
Version Model Number16455
Catalog Number16455
Company DUNS308547608
Company NameVitrolife A/S
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com
Phone+4570230500
Emailsupport.embryoscope@vitrolife.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105712714000041 [Primary]
GS115712714000048 [Package]
Package: Cardboard box [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQKLabware, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-20

Devices Manufactured by Vitrolife A/S

05712714000041 - EmbryoSlide+ ic8 dish2022-08-29The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer. The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release. The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
05712714000041 - EmbryoSlide+ ic8 dish2022-08-29 The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for
05712714675317 - KIDScore D32019-12-06 The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by sco
05712714604010 - EmbryoScope+2018-07-06 EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an en
05712714663505 - EmbryoSlide culture dish2018-07-06 The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only
05712714664502 - EmbryoSlide+ culture dish2018-07-06 The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reserv
05712714666049 - Micro well group culture dish, 9-well2018-07-06 The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended fo
05712714666063 - Micro well group culture dish, 16-well2018-07-06 The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intende
05712714603013 - EmbryoScope time-lapse incubator2018-03-29 The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for

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