Micro well group culture dish, 16-well

Basic Information

• Brand Name: Micro well group culture dish, 16-well
• Primary DI: 05712714666063
• Version / Model: 16606
• Catalog Number: 16606
• Company Name: Vitrolife A/S
• Labeler DUNS: 308547608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-21
• Public Version: 5
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 5caf3a36-d222-4a8a-84b1-467d1a09e7a7

Device Description

The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture. The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6). Indications for Use / Intended Use: For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	884.6160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56648	Assisted reproduction procedure dish	A container intended exclusively 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 used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05712714666063	GS1
Package	15712714666060	GS1	Card board box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150756	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 25 Degrees Celsius