EmbryoSlide culture dish

Primary DI
05712714663505
Brand
EmbryoSlide culture dish
Company
Vitrolife A/S
Model
FT-S-ES-D
Catalog number
FT-S-ES-D
Device description
The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm.
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQKLabware, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150961000EmbryoSlide Culture DishVitrolife A/S2015-12-04MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15712714663502PackageGS150In Commercial Distribution
05712714663505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1571271466350215712714663502
05712714663505057127146635055712714663505

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction procedure dishA sterile container intended for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4570230500support.embryoscope@vitrolife.
+4570230500support.embryoscope@vitrolife.com
+4572217900order@vitrolife.com

Regulatory Flags#

DUNS number
308547608
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712714676123ES server7166122026-04-16
05712714676222EmbryoViewer7166222026-04-16
05712714000041EmbryoSlide+ ic8 dish16455164552022-08-20
05712714675317KIDScore D316531165312019-11-28
05712714603013EmbryoScope time-lapse incubatorESD20000ESD200002016-08-26
05712714604010EmbryoScope+ES-P1164012018-05-24
05712714664502EmbryoSlide+ culture dish16450164502018-05-24
05712714666049Micro well group culture dish, 9-well16604166042017-09-21
05712714666063Micro well group culture dish, 16-well16606166062017-09-21

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