EmbryoSlide+ culture dish

Primary DI
05712714664502
Brand
EmbryoSlide+ culture dish
Company
Vitrolife A/S
Model
16450
Catalog number
16450
Device description
The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture wells, and each well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient (name, patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10-6 and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
Published
2018-05-24
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
K173264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173264000EmbryoScope+Vitrolife A/S2018-05-11MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15712714664509PackageGS140In Commercial Distribution
05712714664502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1571271466450915712714664509
05712714664502057127146645025712714664502

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

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
05712714663505EmbryoSlide culture dishFT-S-ES-DFT-S-ES-D2016-08-26
05712714666049Micro well group culture dish, 9-well16604166042017-09-21
05712714666063Micro well group culture dish, 16-well16606166062017-09-21

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