Dish for MIRI TL

Basic Information

• Brand Name: Dish for MIRI TL
• Primary DI: 04779041940144
• Version / Model: CultureCoin
• Company Name: ESCO MEDICAL TECHNOLOGIES UAB
• Labeler DUNS: 365831125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2026-01-15
• Public Version: 1
• Public Version Date: 2026-01-23
• Public Version Status: New
• Public Device Record Key: 7501d5fd-94c1-48da-8b31-ab85ef36a216

Device Description

Preparing, storing and transferring human embryos. To be used only with the MIRI TL device.

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: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	884.6120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43344	Tissue culture/microbiology petri dish, single-use	A device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04779041940144	GS1
Unit of Use	04779041940939	GS1

Premarket Submissions

Submission Number	Supplement Number
K151357	000