Culture Dish 40 mm

Basic Information

• Brand Name: Culture Dish 40 mm
• Primary DI: 27350025914484
• Version / Model: 16001
• Company Name: Hertart ApS
• Labeler DUNS: 305164017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2016-06-15
• Public Version: 6
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 642061e5-0fe3-4aef-846d-692803190f20

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	27350025914484	GS1
Unit of Use	07350025914480	GS1

Premarket Submissions

Submission Number	Supplement Number
K123641	000